Corporate Events

Daiichi Sankyo will present new clinical research across its DXd antibody drug conjugate (ADC) portfolio in lung cancer at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC25). Data at WCLC will showcase the company's progress towards creating new standards of care for patients with lung cancer, including a late-breaking oral presentation featuring the primary analysis from the dose optimization and dose expansion parts of the IDeate-Lung01 phase 2 trial (OA06.03) of ifinatamab deruxtecan (I-DXd) in patients with pretreated extensive-stage small cell lung cancer (ES-SCLC). Interim data from the dose optimization part of the trial was previously presented at 2024 WCLC. Additional data updates at WCLC include an oral presentation featuring a retrospective analysis of the intrracranial efficacy of DATROWAY®? (datopotamab deruxtecan) or docetaxel in patients with non-small cell lung cancer (NSCLC) and baseline brain metastases in the TROPION-Lung01 phase 3 trial (0A10.01), and a poster presentation of the final results of the DESTINY-Lung05 phase 2 trial (P2.10.12) of ENHERTU®? (trastuzumab deruxtecan) in patients from China with previously treated HER2 mutant NSCLC. Several trials-in-progress poster presentations at WCLC further highlight the Daiichi Sankyo R&D strategy of continuing to expand the DXd ADC portfolio to address a broad spectrum of unmet needs for patients with lung cancer, includes the DESTINY- Lung06 phase 3 trial evaluating the efficacy and safety of ENHERTU plus pembrolizumab versus platinum-based chemotherapy plus pembrolizumib as a first-line treatment strategy for patients with HER2 overexpressing, PD-L1 TPS.

ENHERTU®? (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab has been granted Breakthrough Therapy Designation (BTD) in the U.S. for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer. ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and AstraZeneca. The U.S. Food and Drug Administration (FDA) BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The medicine needs to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines. The FDA granted this BTD based on data from the DESTINY-Breast09 phase 3 trial presented during a special late-breaking oral session at the 2025 American Society of Clinical Oncology (#ASCO25) Annual Meeting. Safety and efficacy have not been established. ENHERTU is an HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with: Unresectable or metastatic HER 2-positive (IHC 3+ or ISH positive) breast cancer who have received a prior anti-HER2-based regimen either: In the metastatic setting, or In the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy Unresectable or metast metastatic: Hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or Within 6 months of completing adjuvant chemotherapy Unresectable or metastatics non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test and who have received a prior systemic therapy. This indication is approved under accelerated approval based on objective response rate and duration of response. continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The recommended dosage of ENHERTU has not been established for patients with severe renal impairment (CLcr 3 times ULN and any AST). To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or fda.gov/medwatch.

Daiichi Sankyo Company, Limited, Q1 2026 Earnings Call, Jul 31, 2025

Final long-term efficacy and safety results from the open-label extension of the ENLIVEN phase 3 trial showed a sustained clinical benefit from long-term treatment with TURALIO®? (pexidartinib) in patients with symptomatic tenosynovial giant cell tumor (TGCT) not amenable to improvement with surgery. These results, consistent with the primary analysis of the trial, were recently published in The Oncologist. TURALIO is the first oral systemic therapy approved in the U.S. for adult patients with TGCT associated with severe morbidity or functional limitations and not amenable to improvement with operations. TGCT is a rare and typically non-malignant tumor that affects small and large joints. Efficacy outcomes were measured by overall response rate (ORR) by RECIST version 1.1, ORR by tumor volume score (TVS) and mean change in baseline in range of motion of the affected joint at Week 25. Study results from the first part of ENLIVEN showed an ORR of 38% (95% confidence interval [CI]: 27-50) in patients treated with TURALIO compared to an ORR of 0% (95% CI: 0-6) in patients treated with placebo as assessed by RECIST. An ORR by TVS of 56% (95% CI: 43-67) in patients treated with TurALIO and 0% in patients treated with placebo also was shown. A total of 91 patients received TURALIO during the second part of the study as of data cut-off of April 30, 2021. Serious TEAEs were reported in 23.1% of patients who received TURALIO in the ENLIVEN study. Due to the risk of hepatotoxicity, TURALIO is only available through a restricted program called the TURALIO Risk Evaluation and Mitigation Strategy (REMS) Program. TURALIO can cause serious and potentially fatal liver injury, including devastating bile duct syndrome. After completing the first part of the trial, patients randomized to either TURALIO or placebo were eligible to enter the second part of ENLIVEN, a long-term, open-label portion of the trial where 91 patients either crossed over from placebo to receive TURALIO 800 mg twice a day (without loading dose) or continued the dose of TURALIO received at the end of part 1 until tumor progression, toxicity, or study completion. Results from this portion of the trial were published in The Oncologist; TURALIO is available only through a restricted program called theTURALIO Risk Evaluation andMitigation Strategy (REMS) program. Of the first 609 patients who received TURALio under the REMS program, 32 (5.3%) developed a liver injury event of concern, defined as any serious liver-related outcome or any liver abnormality that triggers drug discontinuation per the US Prescribing Information. Among 768 patients who received TURAL IO in clinical trials, there were two irreversible cases of cholestatic liver injury. To report a patient patient with TURALIO in the U.S. and the primary analysis of the trial was published in The Oncologist, Dana-Farber Cancer Institute and Harvard Medical School.

From April 25, 2025 to June 30, 2025, the company has repurchased 0 shares, representing 0% for ¥0 million. With this, the company has completed the repurchase of 0 shares, representing 0% for ¥0 million under the buyback announced on April 25, 2025.

Datroway has been approved in the US for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The approval follows Priority Review and Breakthrough Therapy Designation by the Food and Drug Administration (FDA) based on results from a subgroup analysis of the TROPION-Lung05 Phase II trial and supported by data from the TROPION-L Lung01 Phase III trial. In TROPION-Lung01, Datroway demonstrated a confirmed ORR of 45% (95% confidence interval [CI]: 35-54) in patients with previously treated locally advanced or metastatic EGR-mutated NSCLC (n=114) as assessed by blinded independent central review (BICR). Complete responses were seen in 4.4% of patients and partial responses were seen in 40% of patients. The median DoR was 6.5 months (95% CI: 4.2-8.4). The safety profile of Datroway was evaluated in a pooled analysis of 125 patients in the TROPION-Lunung01 Phase II trial and supported by Data from the TROPION- Lung01 Phase III trial.

Daiichi Sankyo Company, Limited, Board Meeting, Jun 23, 2025.

Daiichi Sankyo's VANFLYTA (quizartinib) has been approved by Health Canada for use in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA maintenance monotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FMS-like tyrosine kinase 3- internal tandem duplication (FLT3-ITD) positive. Improvements in overall survival (OS) has not been demonstrated for maintenance monotherapy following allogeneic hematopoietic stem cell transplantation. A validated test is required to confirm the FLT3-ITD status of AML. AML is one of the most common forms of leukemia in adults, representing approximately 80% of all cases.2FLT3 gene mutations occur in approximately 30% of newly diagnosed patients with AML. Approximately 80% of these are FLT3-ITD mutations, which drive cancer growth and contribute to an increased risk of relapse and shorter overall survival.3,4FLT3-ITD mutations occur in roughly 25% of all AML cases, with some studies reporting a frequency as high as 30%. The five-year survival rate for Canadian patients with AML receiving the current standard of care has been reported at approximately 23%. VANFLYTA is a novel selective FLT3-ITD inhibitor that when used in combination with standard chemotherapy and across all three phases of treatment: induction, consolidation and maintenance, provides proven survival outcomes in newly diagnosed FLT3-ITD positive AML - even in a population of adults up to 75 years of age. The approval of VANFLYTA by Health Canada was based on the results of the QuANTUM-First phase 3 clinical trial. In QuANTUM-First, VANFLYTA combined with standard cytarabine induction and standard Cytarabine consolidation and continued as maintenance monotherapy following consolidation, demonstrated a 22.4% reduction in the risk of death compared to standard chemotherapy alone (HR = 0.78 [95% CI: 0.62-0.98; 2-sided p=0.0324]) in patients with newly diagnosed FLT3- ITD positive AML.1,6 Median OS was 31.9 months for patients receiving VANFLYTA (n=268; 95% CI: 21.0-NE) compared to 15.1 months for patients in the control arm (n=271; 95% CI: 13.2-26.2) at a median follow-up of 39.2 months.

The first patient has been dosed in the IDeate-Prostate01 phase 3 trial evaluating the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) versus docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC) with disease progression during or after treatment with an androgen receptor pathway inhibitor. Ifinatamab deruxTEcan is a specifically engineered, potential first-in-class B7-H3 directed DXd antibody drug conjjugate (ADC) discovered by Daiichi Sankyo and Merck, known as MSD outside of the United States and Canada. While localized prostate cancer has a five-year survival rate of more than 90%, survival decreases to 31% in the advanced or metastatic stage. Current standard of care for patients with mCRPC includes treatment with androgen receptor pathway inhibitors followed by taxane-based chemotherapy.2-5 However, due to poor prognosis associated with previously treated mCRPC, many patients do not receive subsequent therapy, reinforcing the need for new approaches to improve outcomes. Ifinatamab Deruxtecan has been granted orphan drug designation by the U.S. Food and Drug Administration, European Commission, Japan Ministry of Health, Labour and Welfare and Taiwan Food and Drug Administration for the treatment of small cell lung cancer. A comprehensive global clinical development program is underway evaluating the efficacy and safety of ifinatamab deroxtecan across multiple B7-H3 targetable cancers. Trials in combination with other anticancer treatments also are underway.

Daiichi Sankyo Company, Limited announced that they will report Q1, 2026 results at 1:00 PM, Tokyo Standard Time on Jul 31, 2025

ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca . positive results from the DESTINY-Gastric04 phase 3 trial showed ENHERTU®? (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to ramucirumab plus paclitaxel in patients with second-line HER2 positive (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or gastroesophageal junction (GEJ) adocarcinoma. Results will be presented as a late-breaking oral presentation (LBA #4002) at the 2025 American Society of Clinical Oncology (#ASCO25) Annual Meeting and simultaneously published in The New England Journal of Medicine. The safety profile of ENHERTU in DESTINY-GASTric04 was consistent with previous gastric cancer clinical trials with no new safety concerns identified. The most common grade 3 or higher treatment related adverse events occurring in patients treated with ENHERTU were neutropenia (28.7%), anemia (13.9%), thrombocytopenia (8.6%), leukopenia (7.4%) and fatigue (7.0%).

results from three trials continue to demonstrate the potential of DATROWAY® (datopotamab deruxtecan) in combination with various immunotherapies to improve outcomes in patients with non-small cell lung cancer (NSCLC) across multiple stages of the disease. These results from TROPION-Lung02, TROPION-Lung04 and NeoCOAST-2 were presented at the 2025 American Society of Clinical Oncology (#ASCO25) Annual Meeting. DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and AstraZeneca. Secondary endpoints include ORR, DoR, PFS as assessed by investigator, overall survival, pharmacokinetics and anti-drug antibodies for DATROWAY and pembrolizumab. TROPION-Lung2 is one of three clinical trials along with the phase 3 TROPION-Lung07 and TROPION-Lung08 trials in a collaboration and supply agreement between Daiichi Sankyo, AstraZeneca and Merck (known as MSD outside of the United States and Canada) to evaluate the combination of DATROWAY and Pembrolizumab.TROPION-Lung02 enrolled 145 patients in Asia, Europe and North America. Rilvegostomig is AstraZeneca's PD-1/TIGIT bispecific antibody. The TIGIT component of rilvegostomig are derived from the clinical-stage anti-TIGIT antibody, COM902, developed by Compugen Ltd. TROPION-L Lung04 will enroll more than 370 patients in Asia, Europe andNorth America. The recommended dosage of DATROWAY has not been established for patients with severe hepatic impairment (total bilirubin >3 times ULN and any AST). To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or fda.gov/medwatch.

The positive results from the DESTINY-Breast09 phase 3 trial showed ENHERTU®? (trastuzumab deruxtecan) plus pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to taxane, trastuzumab and pertuzumab (THP) as a first-line treatment in patients with HER2 positive metastatic breast cancer. Results will be presented during a special late-breaking oral session (LBA #1008) at the 2025 American Society of Clinical Oncology (#ASCO25) Annual Meeting. ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and AstraZeneca. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. ENHERTU is an HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with: Unresectable or metastatic HER2-positive (IHC 3+ or ISH positive) breast cancer who have received a prior anti-HER2-based regimen either: In the metastatic setting, or In the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy Unresectable or metast metastatic: Hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting; HER2-low (IHC 1+ or IHC2+/ISH-) breast cancer, as determined by a FDA-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or Within 6 months of completing adjuvant chemotherapy; Unresectable or metastatics non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test; and who have received a prior systemic therapy. This indication is approved under accelerated approval based on objective response rate and duration of response. The recommended dosage of ENHERTU has not been established for patients with severe renal impairment (CLcr 3 times ULN and any AST).

The Biologics License Application (BLA) seeking accelerated approval in the U.S. for Daiichi Sankyo and Merck's, known as MSD outside of the United States and Canada, patritumab deruxtecan (HER3-DXd) based on the HERTHENA-Lung01 phase 2 trial for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies has been voluntarily withdrawn. The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 phase 3 trial where OS did not meet statistical significance as well as discussions with the U.S. Food and Drug Administration. The decision is unrelated to the Complete Response Letter that was received in June 2024 and outlined findings pertaining to an inspection of a third-party manufacturing facility. Patritumab deruxte can is a specifically engineered HER3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo, and Merck. The safety profile seen in HERTHena-Lung02 was consistent with that observed for patritumab deruxTEcan in previous lung cancer clinical trials with no new safety signals identified.

IHH Healthcare Berhad announced refer to its earlier announcements dated 13 July 2018, 15 August 2018, 13 November 2018, 17 December 2018, 18 November 2019, 3 February 2020, 5 March 2020, 17 March 2020, 14 August 2020, 22 September 2022, 23 September 2022, 26 September 2022, 11 November 2022, 17 November 2022, 14 November 2023, 24 November 2023, 26 December 2023, 2 February 2024, 22 February 2024, 18 April 2024, 14 May 2024, 2 August 2024, 21 August 2024, 7 November 2024 and 6 February 2025 (the announcements) in relation to the Transaction. Unless otherwise expressed or defined herein, all capitalised terms used in this announcement shall have the same meanings as ascribed to them in the Said Announcements (or any of them). The board of directors of announced on 9 May 2025, NTK has submitted to the Court a petition to increase NTK's claim against Daiichi Sankyo ("Petition to Increase Claim") and the copy of the Petition to Increase Claim was delivered to Daiichi Sankyo by the Court on 20 May 2025. The Petition to Increase Claim was made pursuant to NTK's previous submission of the 6 February 2025 Brief to the Court together with the OP Report, being an expert report by NTK's appointed expert which includes an analysis and quantification of the damages suffered by NTK based on three counterfactual scenarios had the Open Offers proceeded. In the Petition to Increase Claim, NTK has sought, amongst others, to amend the amount of the damages claimed from the initial amount of JPY 20 billion (equivalent to MYR 634 million) to: (i) INR 109,299,359,054 (equivalent to MYR 5,708,268,325.95 and JPY 199,785,395,700.48) for losses arising from NTK's tortious claim (other than defamation) against Daiichi Sankyo; (ii) JPY 5,000,000 (equivalent to MYR 142,860.00 and INR 2,735,419.14) for losses arising from NTK's defamation claim against Daiichi Sankyo; and (iii) the accrued interest on the damages claimed. NTK has reserved its rights to further amend the amount of damages in the Petition to Increase Claim. The next hearing before the Court is scheduled for 11 July 2025.

Daiichi Sankyo will present new clinical research across its oncology portfolio with more than 20 abstracts in multiple cancers at the 2025 American Society of Clinical Oncology Scientific Program (#ASCO25). Updated results from the PRO-DUCE study (#1545) examining vital sign monitoring compared to usual care in patients with metastatic breast cancer receiving ENHERTU also will be highlighted as a poster presentation. Details of the two late-breaking ENHERTU oral presentations at ASCO 2025 include: Lastuzumab deruxtecan (T-DXd) + pertuzumab vs taxane + trastuzumab + pertuzumab (THP) for first-line S. Tolaney LBA1008 Special LBA Session treatment of patients with human epidermal growth factor receptor 2 positive (HER2+) advanced/metastatic breast cancer: interim results from DESTINY-Breast09Oral Presentation Monday, June 2, 7:30 - 8:00 am Trastuzumab deruxTEcan (T-DXd), ramucirumab plus paclitaxel in second-line treatment of patients K. Shitara LBA4002 Oral Presentation with human epidermal growth factors receptor 2 positive (HER2+ unresectable/metastatic gastric cancer or gastroesophageal junction adenocarcinoma: primary analysis of the randomized, phase 3 DESTINY-Gastric04 study. Highlights of additional clinical data and trials-in-progress from Daiichi Sankyo's oncology pipeline include: Breast Exploratory biomarker analysis of trastuzumab deruxcocan (T-DXd). Dr. Dent 1013: physician's choice of chemotherapy in HER2 low/ultralow, hormone receptor-positive (HR+) metastatic breast cancer in DESTINY-BreAST06 Saturday, May 31 1:15 - 4:15 pm HERTHENA-Breast03: a phase 2, randomized, open-label study evaluating J. TPS629 Poster Sessionneoadjuvant patritumab deruxtecan + pembrolizumab before or after pembrolizumab + chemotherapy for early-stage TNBC or HR-low+/HER2- breast cancer: Electronic patient-reported outcomes with vital sign monitoring versus usual Y. Kikawa 1545 Poster Session care during trastuzumab deroxtecan treatment for metastatic breast cancer: updated results from the PRO-D UCE study Sunday, June 1 9:00 am - 12:00 pm Lung TROPION-Lung02: datployamab deruxtecan (Dato-DXd) plus pembrolizumab with or B. Levy 8501 Oral Presentation without platinum chemotherapy as first-line therapy for advanced non-small cell lung cancer: without platinum chemotherapy as first- line therapy for advanced non-smallcell lung cancer: A Phase 2, randomized, open- label study evaluating J. TPS2: pembrolizumab deruxtecan+ pembrolizumab after or after pembrolizUMab + chemotherapy for early- stage TNBC or HR-low +/HER2- breast cancer.

Daiichi Sankyo Company, Limited provided dividend guidance for the Second quarter end and Fiscal year ending March 31, 2026. For the Second quarter end, the company Forecasts dividend of JPY 39.00 per share as compared to JPY 30.00 per share paid a year ago. For the Fiscal year, the company Forecasts dividend of JPY 39.00 per share dividend as compared to JPY 30.00 per share paid a year ago.

Daiichi Sankyo Company, Limited announced dividend of JPY 30.00 per share for the fiscal year-end ended March 31, 2025 as compared to JPY 30.00 per share paid a year ago. Scheduled date of dividend payments: From June 24, 2025.

Daiichi Sankyo Company, Limited provided consolidated earnings guidance for the fiscal year ending March 31, 2026. For the period, the company expects revenue to be JPY 2,000,000 million, Operating profit to be JPY 350,000 million, profit for the year to be JPY 300,000 million or JPY 160.72 per basic share.

Daiichi Sankyo Inc. Announced positive topline results from the DESTINY-Breast11 phase 3 trial showed ENHERTU®? (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab and pertuzumab (THP) demonstrated a statistically significant and clinically meaningful improvement in pathologic complete response (pCR) rate versus standard of care (dose-dense doxorubicin and cyclophosphamide followed by THP [ddAC-THP) when used in the neoadjuvant setting (before surgery) in patients with high-risk, locally advanced HER2 positive early-stage breast cancer. Pathologic complete response is defined as no evidence of invasive cancer cells in the removed breast tissue and lymph nodes following treatment. The secondary endpoint of event-free survival (EFS) was not mature at the time of this analysis; however, EFS data showed an early positive trend favoring ENHERTU followed by THP compared to standard of care. Following a recommendation by the Independent Data Monitoring Committee, patient enrollment in a third arm of the study evaluating ENHERTU alone was closed based on a previous interim efficacy assessment of the study arms. Data from DESTINY-BreAST11 will be presented at an upcoming medical meeting and shared with regulatory authorities. ENHERTU has demonstrated improved outcomes in six phase 3 breast cancer trials across different subtypes and stages of disease, including the recently announced DESTINY-Bre metastatic09 trial in the first-line HER2 positive metastatic setting. Safety and efficacy have not been established. ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with: Unresectable or metastatic HER2-positive (IHC 3+ or ISH positive) breast cancer who have received a prior anti-HER2-based regimen either: In the metastatic setting, or In the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy Unresectable or metast metastatic: Hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during and within 6 months of completing adjuvant chemotherapy. Unresectable or metastatics non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA- approved test, and who have received a prior systemic therapy. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The recommended dosage of ENHERTU has not been established for patients with severe renal impairment (CLcr 3 times ULN and any AST).

Daiichi Sankyo Company, Limited, Annual General Meeting, Jun 23, 2025.

The Board of Directors of Daiichi Sankyo Company, Limited has authorized a buyback plan on April 25, 2025.

Daiichi Sankyo Company, Limited (TSE:4568) announces a share repurchase program. Under the program, the company will repurchase 80,000,000 shares, representing 4.29% of its share capital, for ¥200,000 million. The company will repurchase its shares in order to to further enhance shareholder value through increased dividends and flexible share buybacks. The program will run until March 24, 2026. As of March 31, 2025, the company had 1,866,653,341 shares outstanding (excluding treasury shares) and 41,668,788 shares in treasury.

Daiichi Sankyo Company, Limited expected to report Q1 2026 results on July 29, 2025. This event was calculated by S&P Global (Created on April 25, 2025).

ASCO Highlights 2025

Daiichi Sankyo Company, Limited, Board Meeting, Apr 25, 2025. Agenda: To consider the dividend.

Daiichi Sankyo Company, Limited Presents at BIO Asia Taiwan 2025, Jul-23-2025 through Jul-28-2025. Venue: TaiNEX 1 & 2, Taipei Nangang Exhibition Center, Taipei, Taiwan. Presentation Date & Speakers: Jul-24-2025, Masatoshi Nagamochi, Masatoshi Nagamochi, Open Innovation Group, Research Innovation Planning Department, Research Function, R&D Division.

Daiichi Sankyo announced positive topline results from a planned interim analysis of the DESTINY-Breast09 phase 3 trial showed ENHERTU (trastuzumab deruxtecan) in combination with pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to taxane, trastuzumab and pertuzumab (THP) as a first-line treatment for patients with HER2 positive metastatic breast cancer. ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and AstraZeneca. The PFS improvement was seen across all pre-specified patient subgroups with ENHERTU in combination with pertuzumib. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. ENHERTU is an HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with: Unresectable or metastatic HER2-positive (IHC 3+ or ISH positive) breast cancer who have received a prior anti-HER2-based regimen either: In the metastatic setting, or In the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy Unresectable or metast metastatic: Hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting; HER2-low (I HC 1+ or IHC 2-ultralow (I HC 0 with membrane staining) Breast cancer, as determined by anF FDA-approved test, that have progressed on one or more end endocrine therapies in the metastatics setting; HER2-low ("IHC 1+ or I HC 2+/ISH-) breast cancer, as determined by a FDA-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or Within 6 months of completing adjuvant chemotherapy; Unresectable or metastatics non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test; and who have received a prior systemic therapy. This indication is approved under accelerated approval based on objective response rate and duration of response. The recommended dosage of ENHERTU has not been established for patients with severe renal impairment (CLcr 3 times ULN and any AST).

Daiichi Sankyo Company, Limited, 2025 Earnings Call, Apr 25, 2025

Daiichi Sankyo Company, Limited, 2025 Earnings Call, Apr 25, 2025

Daiichi Sankyo Company, Limited, Board Meeting, Feb 28, 2025. Agenda: To consider and approve the the acquisition of its own shares; and to consider any other matters.

The company closed its plan on April 8, 2025.

From April 1, 2025 to April 8, 2025, the company has repurchased 4,069,300 shares, representing 0.22% for ¥14,588.82 million. With this, the company has completed the repurchase of 13,971,600 shares, representing 0.74% for ¥49,999.9 million under the buyback announced on February 28, 2025.

Daiichi Sankyo and AstraZeneca's DATROWAY has been approved in the European Union (EU) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting. DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and AstraZeneca. The approval by the European Commission follows the positive opinion of the Committee for Medical Products for Human Use of the European Medicines Agency and is based on results from the TROPION-Breast01 phase 3 trial. In TROPion-Breast01, DATROWAY significantly reduced the risk of disease progression or death by 37% compared to investigator's choice of chemotherapy (hazard ratio [HR]=0.63; 95% confidence interval [CI]: 0.52-0.76; p. About DATROWAY: TROPION-Breast1 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of intravenous DATROWAY (6 mg/kg) once per 21-day cycle versus investigator's choice of single-agent chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in adult patients with unresectable and metastatic HR positive, HER2 negative (IHC 0, IHC 1 + or IHC 2+/ish-) breast cancer who have progressed on and are not suitable for endocrine therapy per investigator assessment and have received at least one prior line of chemotherapy for unresectable or metastatic disease. Crossover between trial arms was not permitted. The dual primary endpoints of TROPION-Breast 01 are PFS as assessed by BICR and OS. Key secondary endpoints include ORR, DoR, investigator-assessed PFS, disease control rate, time to first subsequent therapy and safety. The PFS data and additional results for key secondary endpoints of TROPION -Breast01 were published in the Journal of Clinical Oncology and OS results were presented at a Virtual Plenary session hosted by the European Society for Medical Oncology in February 2025. TROPION- Breast01 enrolled 732 patients in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov.

Fortis Healthcare Limited announced the Hon'ble Delhi High Court had ordered for the sale of the 'Fortis' trademarks and allied marks by way of public auction, as, pursuant to the Hon'ble Supreme Court of India's judgment dated September 22, 2022, the Fortis Marks (which were held by certain entities owned and controlled by the erstwhile promoters of the Company) were attached and made available to the Hon'ble Delhi High Court for satisfaction of a decree in favour of Daiichi Sankyo Company Limited. Pursuant to the aforesaid order, a public auction was conducted, wherein the Company emerged as the successful bidder for the Fortis Marks basis its bid of INR 2,000 million. By way of its judgment dated March 25, 2025, the Hon'ble Delhi High Court has confirmed the sale of the Fortis Marks and all attendant rights and liabilities in favour of the Company pursuant to the public auction process. An arbitral award dated April 29, 2016 was passed by a Singapore arbitral tribunal in favour of Daiichi Sankyo Company Limited ("Daiichi") and against 20 respondents (including against a company called RHC Holding Private Limited ("RHC Holding")). The arbitral award has attained finality and is now a decree in favour of Daiichi ("Decree"), that is being executed by the Hon'ble High Court of Delhi ("Delhi High Court"). RHC Holding was the legal and beneficial owner of the 'Fortis' trademarks and allied trademarks ("Fortis Marks") and had granted the Company a non-exclusive license to use the Fortis Marks under a brand licensing arrangement. At some point in 2017, RHC Holding assigned and transferred all rights in the Fortis Marks to RHC Healthcare Management Services Private Limited ("RHC Healthcare"). Thereafter, vide judgment dated September 22, 2022, the Hon'ble Supreme Court of India held that all the properties of Malvinder Mohan Singh and Shivinder Mohan Singh (the erstwhile promoters of the Company), shall be available to the Delhi High Court in its capacity as the executing court, and that all such properties (including the Fortis Marks) stand attached and are available for the Delhi High Court to pass such directions as it may deem appropriate to pass. In connection with the satisfaction of the Decree, and pursuant to the aforesaid attachment of the Fortis Marks, Daiichi had filed before the Delhi High Court certain applications praying for the appointment of a Court Commissioner for the purposes of carrying out the sale of the Fortis Marks. Vide order dated October 29, 2024 ("Public Auction Order"), the Delhi High Court had ordered for the sale of the Fortis Marks by way of public auction and appointed a Joint Registrar (Judicial) of the Delhi High Court ("Joint Registrar") for this purpose. Pursuant to the terms of the Public Auction Order, a public auction was carried out on December 21, 2024 as per the procedures and conditions of sale stipulated by the Delhi High Court. Upon completion of the public auction, and during the course of proceedings for the confirmation of the sale of the Fortis Marks in the Company's favour, RHC Healthcare filed objections before the Delhi High Court, inter alia in respect of the valuation of the Fortis Marks, and certain process-related aspects in respect of the public auction.

Daiichi Sankyo Company, Limited Presents at German Biotech Days 2025, Apr-09-2025 . Venue: Heidelberg, Germany. Speakers: Takashi Kagari.

Daiichi Sankyo and AstraZeneca's ENHERTU®? (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment. ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo. The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on results from the DESTINY-Breast06 phase 3 trial presented at the 2024 American Society of Clinical Oncology (#ASCO24) Annual Meeting and published in The New England Journal of Medicine. HR positive, HER2 negative is the most common breast cancer subtype, accounting for approximately 70% of all breast cancers. Despite being classified as HER2 negative, many of these tumors still have some level of HER2 expression. Currently, regardless of HER2 expression, endocrine-based therapies are widely used in the early lines of treatment for HR positive metastatic breast cancer. Following endocrine-based therapy, some patients discontinue treatment, and others are treated with conventional chemotherapy which is associated with poor response rates and outcomes. Following this approval in the EU, an amount of $125 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment for the HER2 low and HER2 ultralow chemotherapy-naive breast cancer indication. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatugug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

From February 28, 2025 to March 31, 2025, the company has repurchased 9,902,300 shares, representing 0.53% for ¥35,411.08 million. With this, the company has completed the repurchase of 9,902,300 shares, representing 0.53% for ¥35,411.08 million under the buyback announced on February 28, 2025.

Daiichi Sankyo's DATROWAY® (datopotamab deruxtecan) has been launched in Japan for the treatment of adult patients with hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer after prior chemotherapy. DATROWAY is the first ever TROP2 directed medicine to be launched in Japan for HR positive, HER2 negative breast cancer and is the second DXd antibody drug conjugate (ADC) available based on Daiichi Sankyo's DXd ADC Technology. Marketing approval of DATROWAY was granted by the Japan Ministry of Health, Labour and Welfare (MHLW) in December 2024 based on the results from the TROPION-Breast01 phase 3 trial where DATROWAY significantly reduced the risk of disease progression or death by 37% compared to investigator's choice of chemotherapy (hazard ratio [HR]=0.63, 95% confidence interval [CI]: 0.52-0.76; p<0.0001) in patients with HR positive, HER2 negative metastatic breast cancer as assessed by blinded independent central review (BICR). Median progression-free survival (PFS) was 6.9 months in patients treated with DATROWAY compared to 4.9 months in those treated with chemotherapy. In TROPION-Breast01, adverse reactions occurred in 93.6% (337/360 patients) of the 360 patients (including 31 Japanese patients) in the DATROWAY (6 mg/kg) arm. The most common adverse reactions included nausea (51.1%), stomatitis (50.0%), alopecia (36.4%), fatigue (23.6%) and dry eye (21.7%). In Japanese patients, interstitial lung disease (ILD) occurred in 6.5% of patients treated with DATROWAY. DATROWAY is approved in Japan with a Warning for ILD. As cases of ILD, including fatal cases, have occurred in DATROWAY-treated patients, DATROWAY is to be used in close collaboration with a respiratory disease expert. Patients should be closely observed during therapy by monitoring for early signs or symptoms of ILD (such as dyspnea, cough or fever) and performing periodical percutaneous oxygen saturation (SpO2) tests, chest X-ray scans and chest CT scans. If abnormalities are observed, discontinue administration of DATROWAY and take appropriate measures, such as corticosteroid administration. Prior to initiation of DATROWAY therapy, a chest CT scan should be performed and medical history taken to confirm the absence of any comorbidity or history of ILD with the patient and carefully consider the eligibility of the patient for DATROWAY therapy. Additional regulatory submissions for DATROWAY in breast cancer are under review in the EU, China and other regions. TROPION-Breast01 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of intravenous DATROWAY (6 mg/kg) once per 21-day cycle versus investigator's choice of single-agent chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who progressed on and are not suitable for endocrine therapy per investigator assessment and have received at least one additional systemic therapy for unresectable or metastatic disease. Following disease progression or discontinuation of DATROWAY or chemotherapy, patients had the option to receive subsequent treatment at the discretion of their physician. Crossover between trial arms was not permitted. The dual primary endpoints of TROPION-Breast01 are PFS as assessed by BICR and overall survival (OS). Key secondary endpoints include overall response rate, duration of response, investigator-assessed PFS, disease control rate, time to first subsequent therapy and safety. The PFS data and additional results for key secondary endpoints of TROPION-Breast01 were published in the Journal of Clinical Oncology. The OS data were presented at a Virtual Plenary session hosted by the European Society for Medical Oncology in February 2025. TROPION-Breast01 enrolled 732 patients in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov. DATROWAY (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the U.S. only) is a TROP2 directed ADC. Designed using Daiichi Sankyo's proprietary DXd ADC Technology, DATROWAY is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca's ADC scientific platform. DATROWAY is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. DATROWAY is approved in Japan and the U.S. for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results from the TROPION-Breast01 trial. A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of DATROWAY across multiple cancers, including non-small cell lung cancer, triple negative breast cancer and HR positive, HER2 negative breast cancer. The program includes eight phase 3 trials in lung cancer and five phase 3 trials in breast cancer evaluating DATROWAY as a monotherapy and in combination with other anticancer treatments in various settings.

Bio Deutschland eV, German Biotech Days 2025, Apr 09, 2025 through Apr 10, 2025. Venue: Heidelberg, Germany. The German Biotech Days – in German abbreviated DBT – bring together entrepreneurs with scientists and partners from politics, investors, funding institutions and administration.

Nosis Biosciences announced it entered into a Research Collaboration and Option Agreement with Daiichi Sankyo. The collaboration will leverage Nosis' Connexa platform, an advanced AI-powered drug design and delivery system, to enable therapeutic access to extrahepatic cell types across multiple vital organs affected by chronic diseases. Nosis' proprietary Connexa platform represents a breakthrough in RNA medicine by offering the ability tosilence any gene, in any cell type, throughout the body. This technology significantly expands the reach of RNA-based therapies beyond the liver, enabling targeted treatment for critical organs such as the heart, brain, lungs, kidneys, and muscles - areas where effective treatments are currently lacking. RNA-based therapeutics have shown great promise in treating genetic diseases, but their potential has been limited due to delivery challenges, primarily focused on liver-targeted therapies. Connexa overcomes this barrier by integrating AI-powered drug design, single-cell receptor biology, and high-throughput chemistry to develop delivery vehicles optimized for in vivo use. The platform has mapped over 2,900 receptor targets across 532 cell types, ensuring precise delivery while optimizing the therapeutic payload for each disease target.

Daiichi Sankyo Company, Limited announced that they will report fiscal year 2025 results at 1:00 PM, Tokyo Standard Time on Apr 25, 2025

Daiichi Sankyo Company, Limited (TSE:4568) announces a share repurchase program. Under the program, the company will repurchase 17,000,000 shares, representing 0.91% of its share capital, for ¥50,000 million. The company will repurchase its shares in order to enhance shareholder returns and improve capital efficiency. The program will run until April 24, 2025. As of January 31, 2025, the company had 1,877,212,461 shares outstanding (excluding treasury shares) and 31,109,668 shares in treasury.

The Board of Directors of Daiichi Sankyo Company, Limited has authorized a buyback plan on February 28, 2025.

Taiwan Bio Industry Organization, Biotechnology Innovation Organization, BIO Asia Taiwan 2025, Jul 23, 2025 through Jul 28, 2025. Venue: TaiNEX 1 & 2, Taipei Nangang Exhibition Center, Taipei, Taiwan.

Daiichi Sankyo Company, Limited Presents at Global Life Science Partnering and Investor Conference, Feb-26-2025 04:30 PM. Venue: THE LODGE AT TORREY PINES, LA JOLLA, California, California, United States. Speakers: Mark Paris, Executive Director, Oncology Search and Evaluation.

Oncology Business Briefing

Daiichi Sankyo's Datopotamab deruxtecan (Dato-DXd) has been recommended for approval in the European Union (EU) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the TROPION-Breast01 phase 3 trial published in the Journal of Clinical Oncology. The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU. In TROPION-Breast 01, datopotamab deruxte can significantly reduced the risk of disease progression or death by 37% compared to investigator's choice of chemotherapy (hazard ratio [HR]=0.63; 95% confidence interval [CI]: 0.52-0.76; p.76; p. about TROPion-Breast01:TROPION-Breast01 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of intravenous datployamab deruxte can (6 mg/kg) once per 21-day cycle versus investigator's choice of single-agent chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in adult patients with unresectable and metastatic HR positive, HER2 negative (IHC 0, IHC 1 + or IHC 2+/ish-) breast cancer who have progressed on and are not suitable for endocrine therapy per investigator assessment and have received at least one prior line of chemotherapy for unresectable or metastatic disease. Following disease progression or discontinuation of datopotamab deruxTEcan or chemotherapy, patients had the option to receive a subsequent treatment at the discretion of their physician. Crossover between trial arms was not permitted. The dual primary endpoints of TROPION-Breast1 are PFS as assessed by BICR and OS. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan, a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co. Inc, Rahway, NJ, USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload.DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Ifinatamab deruxTEcan, patritumab deruxte can, raludotatug Deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

The first patient has been dosed in the TROPION-Lung12 phase 3 trial evaluating the efficacy and safety of adjuvant DATROWAY® (datopotamab deruxtecan) plus rilvegostomig or rilvegostomig monotherapy versus standard of care in patients with stage 1 adenocarcinoma non-small cell lung cancer (NSCLC) after complete surgical resection who are ctDNA-positive or have other high risk pathological features. DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca . Standard treatment for stage 1 NSCLC is tumor resection, but up to 40% of patients may experience disease recurrence. Tumor resection is typically followed by observation but adjuvant chemotherapy and/or immunotherapy may be offered to patients with stage 1b disease who are identified to be at high risk of relapse.4 However, novel strategies to identify high risk patients are needed as well as additional treatment options in the adjuvant setting. Research suggests that ctDNA screening may help identify high risk patients who are most likely to benefit from adjuvant therapy. TROPION-Lung12 is a global, multicenter, three-arm, open-label phase 3 trial where patients will be randomized in a 2:1:2 ratio to evaluate the efficacy and safety of adjuvant DATROWAY (6 mg/kg) in combination with rilvegostomig (750 mg) or rilvegostomig (750 mg) monotherapy versus observation or standard of care adjuvant chemotherapy regimens in those with stage 1 (stage 1a or 1b with tumors < 4 cm) adenocarcinoma NSCLC who are ctDNA-positive (as determined by an investigational ctDNA assay) or have high risk pathological features (as determined by central pathology assessment). The primary endpoint of TROPION-Lung12 is disease-free survival following complete tumor resection as assessed by blinded independent central review in patients treated with adjuvant DATROWAY and rilvegostomig versus those who undergo observation or receive standard of care. Key secondary endpoints include patient-reported physical functions, patient-reported quality of life outcomes, overall survival and safety. TROPION-Lung12 will enroll approximately 660 patients in Asia, Europe, North America and South America. Rilvegostomig is AstraZeneca’s PD-1/TIGIT bispecific antibody. The TIGIT component of rilvegostomig is derived from the clinical-stage anti-TIGIT antibody, COM902, developed by Compugen Ltd. Nearly 2.5 million lung cancer cases were diagnosed globally in 2022.7 NSCLC is the most common type of lung cancer and adenocarcinoma is the most common subtype of NSCLC, accounting for about 40% of all lung cancer cases. For patients with stage 1 NSCLC, standard treatment is tumor resection and observation. For patients with stage 1b disease or those otherwise identified as having a high risk of relapse based on clinical or pathological features, tumor resection may be followed by adjuvant chemotherapy and/or immunotherapy. However, strategies to identify high risk patients are needed as well as more durable and effective treatment options in the adjuvant setting. Research suggests that screening for ctDNA in patients with stage 1 NSCLC may help identify patients most likely to benefit from adjuvant therapy and that combining an immunotherapy with an ADC has the potential to drive deeper and more durable tumor responses. TROP2 is a protein broadly expressed in the majority of NSCLC tumors. There is currently no TROP2 directed ADC approved for the treatment of lung cancer. DATROWAY (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the U.S. only) is a TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, DATROWAY is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. DATROWAY is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. DATROWAY (6 mg/kg) is approved in Japan and the U.S. for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results from the TROPION-Breast01 trial. A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of DATROWAY across multiple cancers, including NSCLC, triple negative breast cancer and HR positive, HER2 negative breast cancer. The program includes eight phase 3 trials in lung cancer and five phase 3 trials in breast cancer evaluating DATROWAY as a monotherapy and in combination with other anticancer treatments in various settings. Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU® in March 2019 and DATROWAY in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY. DATROWAY can cause severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis. In TROPION-Breast01, ILD/pneumonitis occurred in 4.2% of patients treated with DATROWAY, including 0.5% of patients with Grade 3-4 ILD/pneumonitis, and 0.3% with fatal ILD/pneumonitis. Six patients (1.7%) permanently discontinued DATROWAY due to ILD/pneumonitis. The median time to onset of ILD/pneumonitis was 3.5 months (range: 1.2 months to 10.8 months).

Patients were excluded from TROPION-Breast01 for a history of ILD/pneumonitis requiring treatment with steroids or for ongoing ILD/pneumonitis. Monitor patients for new or worsening respiratory symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever) during treatment with DATROWAY. For asymptomatic (Grade 1) ILD/pneumonitis, consider corticosteroid treatment (eg, =0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), promptly initiate systemic corticosteroid treatment (eg, =1 mg/kg/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks. Withhold DATROWAY in patients with suspected ILD/pneumonitis and permanently discontinue DATROWAY if Grade =2 ILD/pneumonitis is confirmed. DATROWAY can cause ocular adverse reactions including dry eye, keratitis, blepharitis, meibomian gland dysfunction, increased lacrimation, conjunctivitis, and blurred vision. In TROPION-Breast01, ocular adverse reactions occurred in 51% of patients treated with DATROWAY. Seven patients (1.9%) experienced Grade 3 ocular adverse reactions, including dry eye, keratitis, and blurred vision. The most common (=5%) ocular adverse reactions were dry eye (27%), keratitis (24%), blepharitis and increased lacrimation (8% each), and meibomian gland dysfunction (7%). Patients with clinically significant corneal disease were excluded from TROPION-Breast01. The median time to onset for ocular adverse reactions was 2.1 months (range: 0.03 months to 23.2 months). Of the patients who experienced ocular adverse reactions, 45% had complete resolution; 9% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade at last follow up). Ocular adverse reactions led to permanent discontinuation of DATROWAY in 0.8% of patients. Advise patients to use preservative-free lubricant eye drops several times daily for prophylaxis. Advise patients to avoid use of contact lenses unless directed by an eye care professional. Refer patients to an eye care professional for an ophthalmic exam including visual acuity testing, slit lamp examination (with fluorescein staining), intraocular pressure, and fundoscopy at treatment initiation, annually while on treatment, at end of treatment, and as clinically indicated. Promptly refer patients to an eye care professional for any new or worsening ocular adverse reactions. Monitor patients for ocular adverse reactions during treatment with DATROWAY, and if diagnosis is confirmed, dose delay, dose reduce, or permanently discontinue DATROWAY based on severity. DATROWAY can cause stomatitis, including mouth ulcers and oral mucositis. In the TROPION-Breast01 study, stomatitis occurred in 59% of patients treated with DATROWAY, including 7% of patients with Grade 3-4 events. Median time to first onset was 0.7 months (range: 0.03 months to 8.8 months). Stomatitis led to interruption of DATROWAY in 1.9%, dosage reductions in 13%, and permanent discontinuation in 0.3% of patients. In patients who received DATROWAY, 38% used a mouthwash containing corticosteroid for management or prophylaxis of stomatitis/oral mucositis at any time during the treatment. Advise patients to use a steroid-containing mouthwash for prophylaxis and treatment of stomatitis. Instruct the patient to hold ice chips or ice water in the mouth throughout the infusion of DATROWAY. Monitor patients for signs and symptoms of stomatitis. If stomatitis occurs, increase the frequency of mouthwash and administer other topical treatments as clinically indicated. Based on the severity of the adverse reaction, withhold, dose reduce, or permanently discontinue DATROWAY. Based on its mechanism of action, DATROWAY can cause embryo-fetal harm when administered to a pregnant woman because the topoisomerase inhibitor component of DATROWAY, DXd, is genotoxic and affects actively dividing cells. Advise patients of the potential risk to a fetus. Advise female patients of reproductive potential to use effective contraception during treatment with DATROWAY and for 7 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with DATROWAY and for 4 months after the last dose. The safety of DATROWAY was evaluated in 360 patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who received at least one dose of DATROWAY 6 mg/kg in TROPION-Breast01. DATROWAY was administered by intravenous infusion once every three weeks. The median duration of treatment was 6.7 months (range: 0.7 months to 16.1 months) for patients who received DATROWAY. Serious adverse reactions occurred in 15% of patients who received DATROWAY. Serious adverse reactions in >0.5% of patients who received DATROWAY were urinary tract infection (1.9%), COVID-19 infection (1.7%), ILD/pneumonitis (1.1%), acute kidney injury, pulmonary embolism, vomiting, diarrhea, hemiparesis, and anemia (0.6% each). Fatal adverse reactions occurred in 0.3% of patients who received DATROWAY and were due to ILD/pneumonitis. Permanent discontinuation of DATROWAY due to an adverse reaction occurred in 3.1% of patients. Adverse reactions which resulted in permanent discontinuation of DATROWAY in >0.5% of patients included ILD/pneumonitis (1.7%) and fatigue (0.6%). Dosage interruptions of DATROWAY due to an adverse reaction occurred in 22% of patients. Adverse reactions which required dosage interruption in >1% of patients included COVID-19 (3.3%), infusion-related reaction (1.4%), ILD/pneumonitis (1.9%), stomatitis (1.9%), fatigue (1.7%), keratitis (1.4%), acute kidney injury (1.1%), and pneumonia (1.1%). Dose reductions of DATROWAY due to an adverse reaction occurred in 23% of patients. Adverse reactions which required dose reduction in >1% of patients included stomatitis (13%), fatigue (3.1%), nausea (2.5%), and weight decrease (1.9%). The most common (=20%) adverse reactions, including laboratory abnormalities, were stomatitis (59%), nausea (56%), fatigue (44%), decreased leukocytes (41%), decreased calcium (39%), alopecia (38%), decreased lymphocytes (36%), decreased hemoglobin (35%), constipation (34%), decreased neutrophils (30%), dry eye (27%), vomiting (24%), increased ALT (24%), keratitis (24%), increased AST (23%), and increased alkaline phosphatase (23%).

Clinically relevant adverse reactions occurring in <10% of patients who received DATROWAY included infusion-related reactions (including bronchospasm), ILD/pneumonitis, headache, pruritus, dry skin, dry mouth, conjunctivitis, blepharitis, meibomian gland dysfunction, blurred vision, increased lacrimation, photophobia, visual impairment, skin hyperpigmentation, and madarosis. Pregnancy: Based on its mechanism of action, DATROWAY can cause embryo-fetal harm when administered to a pregnant woman because the topoisomerase inhibitor component of DATROWAY, DXd, is genotoxic and affects actively dividing cells. There are no available data on the use of DATROWAY in pregnant women to inform a drug-associated risk. Advise patients of the potential risks to a fetus. Lactation: There are no data regarding the presence of datopotamab deruxtecan-dlnk or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with DATROWAY and for 1 month after the last dose. Females and Males of Reproductive Potential: Pregnancy Testing: Verify pregnancy status of females of reproductive potential prior to initiation of DATROWAY. Contraception: Females: Advise females of reproductive potential to use effective contraception during treatment with DATROWAY and for 7 months after the last dose. Males: Because of the potential for genotoxicity, advise male patients with female partners of reproductive potential to use effective contraception during treatment with DATROWAY and for 4 months after the last dose. Infertility: Based on findings in animal toxicity studies, DATROWAY may impair male and female reproductive function and fertility. The effects on reproductive organs in animals were irreversible. Pediatric Use: Safety and effectiveness of DATROWAY have not been established in pediatric patients. Geriatric Use: Of the 365 patients in TROPION-Breast01 treated with DATROWAY 6 mg/kg, 25% were =65 years of age and 5% were =75 years of age. Grade =3 and serious adverse reactions were more common in patients =65 years (42% and 25%, respectively) compared to patients <65 years (33% and 15%, respectively). In TROPION-Breast01, no other meaningful differences in safety or efficacy were observed between patients =65 years of age versus younger patients. Renal Impairment: A higher incidence of ILD/pneumonitis has been observed in patients with mild and moderate renal impairment (creatinine clearance [CLcr] 30 to <90 mL/min). Monitor patients with renal impairment for increased adverse reactions, including respiratory reactions. No dosage adjustment is recommended in patients with mild to moderate renal impairment. The effect of severe renal impairment (CLcr <30 mL/min) on the pharmacokinetics of datopotamab deruxtecan-dlnk or DXd is unknown. Hepatic Impairment: No dosage adjustment is recommended in patients with mild hepatic impairment (total bilirubin =ULN and any AST >ULN or total bilirubin >1 to 1.5 times ULN and any AST). Limited data are available in patients with moderate hepatic impairment (total bilirubin >1.5 to 3 times ULN and any AST). Monitor patients with moderate hepatic impairment for increased adverse reactions. The recommended dosage of DATROWAY has not been established for patients with severe hepatic impairment (total bilirubin >3 times ULN and any AST).

Daiichi Sankyo Company Ltd. has appointed Hiroyuki Okuzawa, 62, to succeed Sunao Manabe, DVM, Ph.D. as Chief Executive Officer (CEO), effective April 1, 2025. Dr. Manabe will transition from his current role of Representative Director, Executive Chairperson and CEO to Representative Director and Executive Chairperson while Mr. Okuzawa will transition to Representative Director, President and CEO. Under Dr. Manabe’s leadership, Daiichi Sankyo’s pioneering science and technology led to the resurgence of antibody drug conjugate (ADC) development within the pharmaceutical industry, leading to three of the largest licensing deals in history along with the approvals of ENHERTU® and DATROWAY®, two precision cancer medicines invented with Daiichi Sankyo’s DXd ADC Technology that are changing the way that metastatic breast cancer is treated. Daiichi Sankyo’s five-year business plan (FY2021-2025) is progressing successfully with the rapid and global expansion of its oncology business. In order to ensure the solid achievement of FY2025 goals and to strengthen its management structure, Daiichi Sankyo’s Board of Directors appointed Mr. Okuzawa as the new CEO at the board meeting on January 31, 2025, based on the Nomination Committee’s report. This transition in April 2025 will occur as Daiichi Sankyo enters the final year of its current five-year business plan and it starts full scale preparation for the next five-year business plan (FY2026-2030). Mr. Okuzawa joined Daiichi Sankyo in 1986 and has served as Representative Director, President and Chief Operating Officer (COO) since 2023. He also held the role of Chief Financial Officer (CFO) for two years and other senior leadership roles in international business, corporate strategy and human resources during his tenure at Daiichi Sankyo. Mr. Okuzawa graduated from Hitotsubashi University in Tokyo with a degree in Social Sciences. Mr. Okuzawa has 50,741 shares of the company as of September 30, 2024.

Daiichi Sankyo Company, Limited Presents at 3rd Operationalise: Early Access Programmes Summit Europe, Oct-07-2024 through Oct-09-2024. Venue: Millennium Gloucester Hotel London Kensington, 4-18 Harrington Gardens, South Kensington, London, United Kingdom. Presentation Date & Speakers: Oct-07-2024, Annie Drellas, Senior Director & Head, Office of Medical Access, Global Oncology Medical Affairs, Laura Carr, Executive Director & Head, GOMA Clinical Trial Management, Resources, Operations, & Governance. Oct-08-2024, Annie Drelles, Senior Director & Head, Office of Medical Access, Global Oncology Medical Affairs.

Daiichi Sankyo Company, Limited Presents at World CDx & LBx Summit APAC, Nov-14-2024 09:30 AM. Venue: Conrad Centennial, 2 Temasek Blvd, Singapore , Singapore. Speakers: Donna Li, Senior CDx Regulatory Affairs Manager.

Daiichi Sankyo Company, Limited Presents at Morgan Stanley 22nd Annual Global Healthcare Conference, Sep-05-2024 09:15 AM. Venue: New York Marriott Marquis, New York, New York, United States. Speakers: Sunao Manabe, Group CEO & Executive Chairperson.

AstraZeneca and Daiichi Sankyo’ ENHERTU (fam-trastuzumab deruxtecan-nxki) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a Food and Drug Administration (FDA)-approved test, that has progressed on one or more endocrine therapies in the metastatic setting. The approval was granted by the FDA after securing Priority Review and Breakthrough Therapy Designation and was based on results from the DESTINY-Breast06 Phase III trial, which were presented at the 2024 American Society of Clinical Oncology (ASCO) Meeting and published in The New England Journal of Medicine. In the trial, ENHERTU showed a 36% reduction in the risk of disease progression or death versus chemotherapy (hazard ratio [HR] 0.64; 95% confidence interval [CI]: 0.54-0.76; p<0.0001) in the overall trial population of patients with chemotherapy-naïve HER2-low or HER2-ultralow metastatic breast cancer. A median progression-free survival (PFS) of 13.2 months was seen in patients randomized to ENHERTUcompared to 8.1 months in those randomized to chemotherapy. The confirmed objective response rate (ORR) in the overall trial population was 62.6% for ENHERTUversus 34.4% for chemotherapy. In an exploratory analysis of patients with HER2-ultralow expression, results were seen to be consistent between patients with HER2-low expression and HER2-ultralow expression. HER2 status in the trial was confirmed by a central laboratory and was performed on a tumor sample obtained at the time of initial metastatic diagnosis or later. Approximately 85-90% of patients with HR-positive, HER2-negative metastatic breast cancer were determined to have actionable levels of HER2-expression. Further, nearly two-thirds of patients previously assessed as IHC 0 at a local laboratory were classified as HER2-low or HER2-ultralow upon central analysis of the tumor sample. The safety profile of ENHERTU in DESTINY-Breast06 was consistent with previous clinical trials of ENHERTUin breast cancer with no new safety concerns identified. ENHERTU is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. ENHERTUis already approved in more than 75 countries, including the US, for patients with HER2-low metastatic breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial. Regulatory applications are under review in the EU, Japan and several other countries based on the DESTINY-Breast06 results. Indications: ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with: Unresectable or metastatic HER2-positive (IHC 3+ or ISH positive) breast cancer who have received a prior anti-HER2-based regimen either: In the metastatic setting, or In the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy Unresectable or metastatic: Hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. Unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH positive) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. Unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options . This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Daiichi Sankyo Company, Limited Presents at ADD Pharmacokinetics & Clinical Pharmacology Summit, Oct-09-2024 02:00 PM. Venue: Hilton Boston Back Bay, 40 Dalton Street, Boston, Massachusetts, United States. Speakers: Li Li, Senior Director, Quantitative Clinical Pharmacology.

Daiichi Sankyo Company, Limited Presents at Veeva R&D and Quality Summit, Oct-31-2024 11:50 AM. Venue: Tokyo, Japan. Speakers: Mark Yale, Executive Director, Head of Global QMS (RDPVMA), Richard Maloney, Senior Director Informatics, Global Applications & Services, Application Delivery & Services, Global DX.

Daiichi Sankyo Company, Limited expected to report Fiscal Year 2025 results on April 25, 2025. This event was calculated by S&P Global (Created on January 16, 2025).

Daiichi Sankyo Company, Limited, Q3 2025 Earnings Call, Jan 31, 2025

Daiichi Sankyo Company, Limited Presents at BIO Partnering @JPM Week, Jan-13-2025 . Venue: San Francisco Marriott Marquis, San Francisco, California, United States.

Daiichi Sankyo and AstraZeneca’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung cancer (NSCLC) who have received prior systemic therapies, including an EGFR-directed therapy. Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca. The U.S. Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for its regulatory decision, is July 12, 2025. Datopotamab deruxtecan was previously granted Breakthrough Therapy Designation (BTD) by the FDA for this patient population. The BLA and BTD are based on data from the TROPION-Lung05 phase 2 trial and supported by data from the TROPION-Lung01 phase 3 trial. In addition, the BLA is supported by the TROPION-PanTumor01 phase 1 trial. In a pooled analysis of patients with previously treated advanced or metastatic EGFR-mutated NSCLC in the TROPION-Lung05 and TROPION-Lung01 trials presented at the European Society for Medical Oncology (ESMO) Asia 2024 Congress, datopotamab deruxtecan demonstrated clinically meaningful tumor response. The safety profile of datopotamab deruxtecan was consistent with previous reports from the TROPION-Lung05 and TROPION-Lung01 trials, with no new safety concerns identified. Daiichi Sankyo and AstraZeneca are evaluating datopotamab deruxtecan alone and in novel combinations as treatment for patients with NSCLC in seven phase 3 trials including the TROPION-Lung14 and TROPION-Lung15 trials of datopotamab deruxtecan alone and with osimertinib, AstraZeneca’s EGFR tyrosine kinase inhibitor (TKI), as treatment for patients with advanced or metastatic EGFR-mutated nonsquamous NSCLC.

The company closed its plan on January 9, 2025.

From January 1, 2025 to January 9, 2025, the company has repurchased 1,953,300 shares, representing 0.1% for ¥8,317.02 million. With this, the company has completed the repurchase of 38,711,900 shares, representing 2.03% for ¥199,999.5 million under the buyback announced on April 25, 2024.

Hanson Wade Limited, 3rd Operationalise: Early Access Programmes Summit Europe, Oct 07, 2024 through Oct 09, 2024. Venue: Millennium Gloucester Hotel London Kensington, 4-18 Harrington Gardens, South Kensington, London, United Kingdom.

Hanson Wade Limited, ADD Pharmacokinetics & Clinical Pharmacology Summit, Oct 08, 2024 through Oct 10, 2024. Venue: Hilton Boston Back Bay, 40 Dalton Street, Boston, Massachusetts, United States.

From October 1, 2024 to December 31, 2024, the company has repurchased 15,230,700 shares, representing 0.8% for ¥71,682.87 million. With this, the company has completed the repurchase of 36,758,600 shares, representing 1.93% for ¥191,682.48 million under the buyback announced on April 25, 2024.

AstraZeneca and Daiichi Sankyo have voluntarily withdrawn the marketing authorisation application (MAA) in the EU for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) based on the TROPION-Lung01 Phase III trial. The decision to withdraw the MAA was informed by feedback from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA). AstraZeneca and Daiichi Sankyo will continue to work to bring datopotamab deruxtecan to patients with lung cancer in the EU who can benefit and are committed to unlocking the potential of this medicine in lung cancer through robust clinical development programme which includes seven pivotal trials in various lung cancer settings. AstraZeneca and Daiichi Sankyo's application in the EU for datopotamab deruxtecan for the treatment of hormone receptor (HR)-positive, HER2-negative metastatic breast cancer based on the TROPION-Breast01 Phase III trial remains under review. Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by AstraZeneca and Daiichi Sankyo.

Daiichi Sankyo and AstraZeneca have voluntarily withdrawn the marketing authorization application (MAA) in the EU for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) based on the TROPION-Lung01 phase 3 trial. The decision to withdraw the MAA was informed by feedback from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA). Daiichi Sankyo and AstraZeneca will continue to work to bring datopotamab deruxtecan to patients with lung cancer in the EU who can benefit and are committed to unlocking the potential of this medicine in lung cancer through robust clinical development program which includes seven pivotal trials in various lung cancer settings. Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca. Daiichi Sankyo and AstraZeneca’s application in the EU for datopotamab deruxtecan for the treatment of hormone receptor (HR) positive, HER2 negative metastatic breast cancer based on the TROPION-Breast01 phase 3 trial remains under review. About TROPION-Lung01 TROPION-Lung01 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan versus docetaxel in adult patients with locally advanced or metastatic NSCLC with and without actionable genomic alterations who require systemic therapy following prior treatment. Patients with actionable genomic alterations were previously treated with an approved targeted therapy and platinum-based chemotherapy. Patients without known actionable genomic alterations were previously treated, concurrently or sequentially, with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor. The dual primary endpoints of TROPION-Lung01 are progression-free survival (PFS) as assessed by blinded independent central review (BICR) and overall survival (OS). Key secondary endpoints include investigator-assessed PFS, objective response rate, duration of response, time to response, and disease control rate as assessed by both BICR and investigator, and safety. TROPION-Lung01 enrolled approximately 600 patients in Asia, Europe, North America, Oceania and South America. For more information visit ClinicalTrials.gov. Primary PFS results and interim OS results from TROPION-Lung01 were presented at the 2023 ESMO (#ESMO23) Congress. Final OS results were presented at IASLC 2024 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC24) and simultaneously published in the Journal of Clinical Oncology in September 2024. About Advanced Non-Small Cell Lung Cancer Nearly 2.5 million lung cancer cases were diagnosed globally in 2022.1 In Europe, nearly 500,000 lung cancer cases were diagnosed in 2022.1 Lung cancer is broadly split into small or non-small cell lung cancer, the latter accounting for about 80% of cases.2 While immunotherapy and targeted therapies have improved outcomes in the first-line setting, most patients eventually experience disease progression and receive chemotherapy.3,4,5 For decades, chemotherapy has been the last treatment available for patients with advanced NSCLC, despite limited effectiveness and known side effects.3,4,5 TROP2 is a protein broadly expressed in the majority of NSCLC tumors.6 There is currently no TROP2 directed ADC approved for the treatment of lung cancer. About Datopotamab Deruxtecan (Dato-DXd) Datopotamab deruxtecan (Dato-DXd) is an investigational TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, datopotamab deruxtecan is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. Datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Additional regulatory submissions in breast cancer are under review in China, Japan, the U.S. and other regions. Datopotamab deruxtecan has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) NSCLC with disease progression on or after treatment with an EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy. Daiichi Sankyo and AstraZeneca have submitted a Biologics License Application for datopotamab deruxtecan for this potential indication. About the Datopotamab Deruxtecan Clinical Development Program A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple cancers, including NSCLC, triple negative breast cancer and HR positive, HER2 low or negative breast cancer. The program includes seven phase 3 trials in lung cancer and five phase 3 trials in breast cancer evaluating datopotamab deruxtecan as a monotherapy and in combination with other anticancer treatments in various settings. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and datopotamab deruxtecan in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and datopotamab deruxtecan. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and datopotamab deruxtecan, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co. Inc., Rahway, N.J. USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo.

A pooled analysis of the TROPION-Lung05 phase 2 and the TROPION-Lung01 phase 3 trials showed datopotamab deruxtecan (Dato-DXd) demonstrated clinically meaningful tumor response in patients with previously treated advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). These data, along with progression-free and overall survival results from the analysis, were presented during a late-breaking proffered paper session (LBA7) at the 2024 ESMO Asia (#ESMOAsia24) Congress. Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca. Datopotamab deruxtecan demonstrated a confirmed objective response rate (ORR) of 42.7% (95% confidence interval [CI]: 33.6-52.2) in a pooled analysis of 117 patients with EGFR-mutated NSCLC from the TROPION-Lung05 (n=78) and TROPION-Lung01 (n=39) trials, as assessed by blinded independent central review (BICR). Five (4.3%) complete responses (CRs), 45 (38.5%) partial responses (PRs) and 48 (41.0%) cases of stable disease (SD) were observed. The median duration of response (DOR) was 7.0 months (95% CI: 4.2-9.8) and the disease control rate (DCR) was 86.3% (95% CI: 78.7-92.0). Median progression-free survival (PFS) was 5.8 months (95% CI: 5.4-8.2) and median overall survival (OS) was 15.6 months (95% CI: 13.1-19.0). Results in patients previously treated with osimertinib were similar to the overall pooled population. In 96 patients previously treated with osimertinib, a confirmed ORR of 44.8% (95% CI: 34.6-55.3), as assessed by BICR was seen. Four (4.2%) CRs, 39 (40.6%) PRs and 37 (38.5%) cases of SD were observed. The median DOR was 6.9 months (95% CI: 4.2-9.8) and the DCR was 85.4% (95% CI: 76.7-91.8). Median PFS was 5.7 months (95% CI: 5.4-7.9) and median OS was 14.7 months (95% CI: 13.0-18.3). The safety profile of datopotamab deruxtecan was consistent with previous reports from the TROPION-Lung05 and TROPION-Lung01 trials, with no new safety concerns identified. The most common treatment-related adverse events (TRAEs) of any grade were stomatitis (59%), alopecia (49%), nausea (46%), fatigue (18%), decreased appetite (16%), constipation (15%), vomiting (12%), rash (11%) and pruritus (10%). Grade 3 or higher TRAEs occurred in 23% of patients. Adverse events of special interest (AESI) of any grade were stomatitis, ocular surface events and adjudicated drug-related interstitial lung disease. No grade 4 or 5 stomatitis, ocular surface events or adjudicated drug-related ILD events occurred. Patients in the pooled analysis received a median of three prior lines of treatment in the metastatic setting (range, 1-5). 82% percent of patients were previously treated with osimertinib, including 40.2% in the first line and 29.1% in the second line. In the pooled population, a range of EGFR mutations was observed, including exon 19 del, exon 21 L858R, exon 20 T790M, exon 18 G719X, exon 21 L861Q, exon 20 ins, and exon 20 C797S.

The first patient has been dosed in the QuANTUM-Wild phase 3 trial evaluating Daiichi Sankyo's VANFLYTA®? (quizartinib) in combination with standard intensive reduction and consolidation chemotherapy followed by single-agent maintenance in adults with newly diagnosed FLT3-ITD negative acute myeloid leukemia (AML). AML is an aggressive blood cancer with a five-year overall survival rate of approximately 32%. Targeted therapy with FLT3 inhibitors has improved survival for some patients with FLT3 gene mutations, which most commonly occur as FLT3-ITD. However, about 90% of patients with AML overexpress FLT3 regardless of mutational status.1,4,5 No FLT3 inhibitors are currently approved for patients without FLT3 mutations. In the U.S., VANFLYTA is not indicated as maintenance monotherapy following allogeneic HSCT; improvement in overall survival with VANFLYTA in this setting has not been demonstrated. VANFLYTA also is approved in Japan for the treatment of patients with relapsed/refractory AML that is FLT3-ITD mutation positive, as detected by an approved test, based on results from the QuANTUM-R trial. The VANFLYTA clinical development program includes the QuANTUM-Wild Phase 3 trial in adult patients with newly diagnosed FLT3 - negative AML, a phase 1/2 trial in pediatric and young adult patients with relapsed/ref refractory FLT3-ITD positive AML in Europe, Asia and North America and several phase 1/2 combination studies as part of a strategic collaboration with The University of Texas MD Anderson Cancer Center. Reduce the VANFLYTA dose when used concomitantly with strong CYP3A inhibitors, as they may increase quizartinib exposure. Because of the risk of QT prolongation, VANFLYTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the VANFLYTA REMS. VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD) -positive as detected by an FDA-approved test. Limitations of Use: VANFLYTA is Not indicated as maintenance monotherapy following Allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VanFLYTA in this setting have not been demonstrated. Torsades de pointes, ventricular fibrillation, cardiac arrest, and sudden death have occurred in patients treated with VANFLYTA. Of the 1,081 patients with AML treated with VANFLY TA in clinical trials, torsades de pointes occurred in approximately 0.2% of patients, cardiac arrest occurred in 0.6% of patients, including 0.4% with a fatal outcome, and 0.1% of patients experienced ventricular fibrillation. These severe cardiac arrhythmias occurred predominantly during the induction phase. Of the 265 patients with newly diagnosed FLT 3-ITD-positive AML treated with VAN FLT3-ITD-positive AM L treated with VANFLYAT in combination with chemotherapy in the clinical trial, 2.3% were found to have a QTcF greater than 500 ms and 10% of patients had an increase from baseline QTcF greater than 60 ms. The clinical trial excluded patients with a QTcF 450 ms or other factors that increased the risk of QT prolongization or arrhythmic events (eg, NYHA Class III or IV congestive heart failure, hypokalemia, family history of long QT interval syndrome). Therefore, avoid use in patients who are at significant risk of developing torsades de pointes, avoid use in patients who is at significant risk of developing torcontrolled or significant cardiac disease, recent myocardial infarction, recent myocardial infARction, recent myocardial Infarction, recent myocardalemia, heart failure, recent myocardial infarsial infarction, recentMyocardial infarction, including myocardial infarction.

Daiichi Sankyo Company, Limited Presents at The 66th American Society of Hematology (ASH) Annual Meeting and Exposition 2024, Dec-07-2024 through Dec-10-2024. Venue: San Diego Convention Center, San Diego, California, United States. Presentation Date(s): Dec-07-2024. Dec-08-2024. Dec-09-2024.

Daiichi Sankyo Company, Limited Presents at European Society for Medical Oncology Asia Congress 2024, Dec-06-2024 through Dec-08-2024. Venue: Singapore. Presentation Date(s): Dec-06-2024. Dec-07-2024.

To discuss latest publications; to discuss R&D strategy and updates; and to discuss Manufacturing and supply activities

Discussion meeting on sustainability (Value Report 2024)

Daiichi Sankyo Company, Limited announced that they will report Q3, 2025 results on Jan 31, 2025

Daiichi Sankyo will highlight new clinical research and real-world data from seven abstracts for TURALIO® (pexidartinib) at the Connective Tissue Oncology Society (#CTOS2024) 2024 Annual Meeting. TURALIO is the first and only oral systemic therapy approved in the U.S. for adult patients with tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. TGCT is a rare and typically non-malignant tumor that affects small and large joints. Data at CTOS will highlight ongoing TURALIO research, including two analyses from the ENLIVEN phase 3 trial. One analysis evaluates the efficacy of TURALIO according to surgical history and the feasibility of surgery following treatment with TURALIO. The other is an exploratory analysis examining the dose of TURALIO at the time of objective response and the first timepoint response of progressive disease in relation to adverse events. Additional TURALIO data at CTOS include health-related quality of life (HRQOL) outcomes from a phase 4 trial evaluating the discontinuation and re-treatment in patients with TGCT previously treated with TURALIO and a trial-in-progress of a phase 4 trial evaluating the risk of idiosyncratic cholestatic hepatoxicity associated with TURALIO treatment. Other clinical research includes interim results from an investigator-initiated phase 1 trial evaluating the safety and tolerability of TURALIO in pediatric patients and young adults with TGCT, a case study reporting the use of TURALIO as an upfront treatment strategy for TCGT and results of a real-world assessment evaluating symptom change in patients with TGCT receiving TURALIO.

Daiichi Sankyo and AstraZeneca have submitted a new Biologics License Application (BLA) for accelerated approval in the U.S. for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung cancer (NSCLC) who have received prior systemic therapies, including an EGFR-directed therapy. The companies have voluntarily withdrawn the BLA in the U.S. for datopotamab deruxtecan for patients with advanced or metastatic nonsquamous NSCLC based on the TROPION-Lung01 phase 3 trial. The decision to submit a new BLA for EGFR-mutated NSCLC and withdraw the previously submitted BLA for nonsquamous NSCLC was informed by feedback from the U.S. Food and Drug Administration (FDA). The new BLA is based on results from the TROPION-Lung05 phase 2 trial and supported by data from the TROPION-Lung01 phase 3 and TROPION-PanTumor01 phase 1 trials. New results from a pooled analysis of patients with previously treated EGFR-mutated NSCLC in the TROPION-Lung05 and TROPION-Lung01 trials will be featured in a late-breaking presentation at the upcoming European Society for Medical Oncology (ESMO) Asia 2024 Congress (LBA7). Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca. Daiichi Sankyo and AstraZeneca are evaluating datopotamab deruxtecan alone and with osimertinib, AstraZeneca’s EGFR tyrosine kinase inhibitor (TKI), as treatment for patients with advanced or metastatic EGFR-mutated nonsquamous NSCLC in the ongoing TROPION-Lung14 and TROPION-Lung15 phase 3 trials. In addition, ongoing phase 3 trials in first-line advanced or metastatic nonsquamous NSCLC, AVANZAR and TROPION-Lung10, have the potential to validate the QCS (quantitative continuous scoring) biomarker for TROP2 identified in an exploratory analysis of TROPION-Lung01. An additional trial in patients with biomarker-positive tumors in the second-line nonsquamous NSCLC setting is also planned. TROPION-Lung05 is a global, multicenter, single-arm, open-label phase 2 trial evaluating the efficacy and safety of datopotamab deruxtecan in patients with locally advanced or metastatic NSCLC with actionable genomic alterations who have progressed on or after one regimen of platinum-based chemotherapy and at least one TKI (with or without other systemic therapies). Patients receiving up to four prior lines of treatment with tumors with one or more genomic alterations including EGFR, ALK, ROS1, NTRK, BRAF, RET or MET were eligible for the trial. The primary trial endpoint of TROPION-Lung05 is objective response rate (ORR) as assessed by blinded independent central review (BICR). Secondary efficacy endpoints include duration of response (DoR), disease control rate (DCR), clinical benefit rate (CBR), progression-free survival (PFS), time to response (TTR), overall survival (OS) and safety. TROPION-Lung05 enrolled 137 patients globally in Asia, Europe and North America.

Alteogen Inc. announced that the company has entered into an exclusive license agreement with Daiichi Sankyo. Under the terms of the agreement, Daiichi Sankyo will acquire world-wide rights to use ALT-B4, Alteogen's novel hyaluronidase utilizing Hybrozyme Technology, to develop and commercialize a subcutaneous version of ENHERTU (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody drug conjugate that has been jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. Alteogen will receive an upfront payment and is eligible to receive milestone payments upon Daiichi Sankyo's achievement of specified development, regulatory and sales milestones. Additionally, Alteogen will be entitled to receive tiered royalties on the sales of the commercialized product. Alteogen will be responsible for clinical and commercial supply of ALT-B4 to Daiichi Sankyo.

The first patients have been dosed in three global, randomized phase 3 trials evaluating the efficacy and safety of datopotamab deruxtecan (Dato-DXd)-based combinations in patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC). Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and AstraZeneca. TROPION-Lung10 is evaluating datopotamab deruxtecan plus rilvegostomig, AstraZeneca’s PD-1/TIGIT bispecific antibody, or rilvegostomig alone versus pembrolizumab in patients with previously untreated locally advanced or metastatic nonsquamous NSCLC with high PD-L1 expression (tumor cells [TC] = 50%) and without actionable genomic alterations. TROPION-Lung14 is evaluating datopotamab deruxtecan plus osimertinib, AstraZeneca’s EGFR tyrosine kinase inhibitor (TKI), versus osimertinib alone in patients with previously untreated locally advanced or metastatic EGFR mutated nonsquamous NSCLC. TROPION-Lung15 is evaluating datopotamab deruxtecan with or without osimertinib versus platinum-based doublet chemotherapy in patients with locally advanced or metastatic nonsquamous EGFR mutated NSCLC whose disease progressed on prior treatment with osimertinib. TROPION-Lung10 is a global, multicenter, open-label, three-arm phase 3 trial where patients will be randomized in a 2:1:2 ratio to evaluate the efficacy and safety of datopotamab deruxtecan (6.0 mg/kg) in combination with rilvegostomig (750 mg) or rilvegostomig (750 mg) monotherapy versus pembrolizumab (200 mg) monotherapy in adult patients with previously untreated locally advanced or metastatic nonsquamous NSCLC with high PD-L1 expression (TC = 50%) and without actionable genomic alterations. The dual primary endpoints of TROPION-Lung10 are progression-free survival (PFS) as assessed by blinded independent central review (BICR) and overall survival (OS) in patients with TROP2 positive tumors receiving datopotamab deruxtecan in combination with rilvegostomig versus the pembrolizumab arm. A pre-specified retrospective analysis from tumor biopsies collected pretreatment will be conducted following validation of a potential TROP2 biomarker determined by quantitative continuous scoring, a computational pathology approach. Key secondary endpoints for all arms of the trial include PFS as assessed by BICR and investigator and OS in the intention-to-treat (ITT) population, objective response rate (ORR) as assessed by BICR and duration of response (DoR) as assessed by BICR and investigator in both TROP2 biomarker positive and the ITT populations. The safety and tolerability of datopotamab deruxtecan in combination with rilvegostomig and rilvegostomig monotherapy as compared with pembrolizumab also will be assessed. TROPION-Lung10 will enroll approximately 675 patients in Asia, Europe, North America, Oceania and South America. TROPION-Lung14 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan (6.0 mg/kg) in combination with osimertinib (80 mg) versus osimertinib (80 mg) monotherapy in adult patients with previously untreated locally advanced or metastatic nonsquamous NSCLC with an EGFR mutation (Exon 19 deletion and/or L858R). The randomized period of the trial is preceded by a single-arm safety run-in period which will enroll approximately 20 patients to evaluate the combination therapy. The primary endpoint of TROPION-Lung14 is PFS as assessed by BICR. Key secondary endpoints include central nervous system (CNS) PFS as assessed by CNS BICR, PFS as assessed by investigator, ORR as assessed by BICR and investigator, OS and safety. TROPION-Lung14 will enroll approximately 580 patients in Asia, Europe, North America, Oceania and South America. TROPION-Lung15 is a global, multicenter, open-label, three-arm phase 3 trial where patients will be randomized in a 1:1:1 ratio to evaluate the efficacy and safety of datopotamab deruxtecan (6.0 mg/kg) as monotherapy or in combination with osimertinib (80 mg) versus platinum-based doublet chemotherapy (pemetrexed in combination with carboplatin or cisplatin followed by pemetrexed maintenance) in adult patients with locally advanced or metastatic nonsquamous NSCLC with at least one EGFR mutation (G719X, Ex19del, S768I, L858R, and/or L861Q) and with disease progression following prior treatment with osimertinib. The dual primary PFS endpoints of TROPION-Lung15 are PFS as assessed by BICR for datopotamab deruxtecan monotherapy versus chemotherapy and datopotamab deruxtecan in combination with osimertinib versus chemotherapy. Key secondary endpoints include investigator-assessed CNS PFS as assessed by CNS BICR, ORR and DoR as assessed by BICR, OS and safety. TROPION-Lung15 will enroll approximately 630 patients in Asia, Europe, North America, Oceania and South America.

Daiichi Sankyo Company, Limited, ¥ 30.0, Cash Dividend, Mar-28-2025

Daiichi Sankyo Company, Limited expected to report Q3 2025 results on January 30, 2025. This event was calculated by S&P Global (Created on October 31, 2024).

Daiichi Sankyo Company, Limited, Q2 2025 Earnings Call, Oct 31, 2024

Daiichi Sankyo Company, Limited Presents at CPHI Milan 2024, Oct-08-2024 11:35 AM. Venue: Milan at Stand 6A2, Milan, Italy. Speakers: Philip Coetzee.

AstraZeneca PLCand Daiichi Sankyo's supplemental Biologics License Application (sBLA) for ENHERTU®? (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2ultralow (IHC 0 with membrane staining) breast cancer who have received at least one endocrine therapy in the metastatic setting based on positive results from the DESTINY-Breast06 Phase III trial which compared ENHERTU to chemotherapy. The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the first quarter of 2025. ENHERTU was also recently granted Breakthrough Therapy Designation (BTD) by the FDA in this setting. BTD accelerates the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need. The sBLA is based on data from the DESTINY -Breast06 Phase III trial presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and recently published in The New England Journal of Medicine. The safety profile of ENHERTU in DestINY-Breast06 was consistent with previous clinical trials of ENHERTUin breast cancer with no new safety concerns identified. Indications: ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients With: Unresectable or metastatic HER 2-positive (IHC 3+ or ISH positive) breast cancer who have received a prior anti-HER2-based regimen either: In the metastatic setting, or In the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy; Unresectable or metastatics HER2-low (IHC 1+ or IHC2+/ISH-) breast cancer, as determined by an FDA-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or Within 6 months of completing adjuvant chemotherapy. Unresectable or metast metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA- approved test, and who have received a prior systemic therapy This indication is approved under accelerated approval based on objective response rate and duration of response. To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or fda.gov/medwatch. Full approval in China for this indication will depend on whether a randomized controlled confirmatory clinical trial can demonstrate clinical benefit in this population. Surveillance, Epidemiology and Endocrine therapy.

Daiichi Sankyo and AstraZeneca's supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer who have received at least one endocrine therapy in the metastatic setting. ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. The U.S. Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is February 1, 2025. The Priority Review follows receipt of Breakthrough Therapy Designation granted by the FDA for ENHERTU based on data from the DESTINY-Breast06 phase 3 trial in August 2024. Hormone receptor (HR) positive, HER2 negative is the most common breast cancer subtype, accounting for approximately 70% of all breast cancers.1 Despite being classified as HER2 negative, many of these tumors still carry some level of HER2 expression.2 It is estimated that up to 85% to 90% of tumors historically classified as HR positive, HER2 negative, may be HER2 low or HER2 ultralow. The sBLA is based on data from DESTINY-Breast06 presented as a late-breaking oral session at the 2024 American Society of Clinical Oncology (#ASCO24) Annual Meeting and recently published in The New England Journal of Medicine. In the overall trial population, ENHERTU reduced the risk of disease progression or death by 37% by blinded independent central review (BICR) versus chemotherapy (hazard ratio [HR] 0.63; 95% confidence interval [CI]: 0.53-0.75; p<0.0001). Median progression-free survival (PFS) was 13.2 months with ENHERTU compared to 8.1 months with chemotherapy. Results were consistent in patients with HER2 low expression and HER2 ultralow expression. In the primary endpoint analysis of patients with HR positive, HER2 low metastatic breast cancer, median PFS was 13.2 months in the ENHERTU arm compared to 8.1 months in the chemotherapy arm (HR 0.62; 95% CI: 0.51-0.74; p<0.0001), as assessed by BICR. In a prespecified exploratory analysis of patients with HER2 ultralow expression, ENHERTU showed a median PFS of 13.2 months versus 8.3 months, respectively (HR 0.78; 95% CI: 0.50-1.21). The safety profile of ENHERTU in DESTINY-Breast06 was consistent with previous breast cancer clinical trials with no new safety concerns identified. The most common grade 3 or higher treatment related treatment emergent adverse events (TEAEs) occurring in 5% or more of patients treated with ENHERTU were neutropenia (20.7%), leukopenia (6.9%) and anemia (5.8%). Interstitial lung disease (ILD) or pneumonitis occurred in 11.3% of patients treated with ENHERTU. The majority of ILD or pneumonitis events were low grade (grade 1 [n=7; 1.6%] or grade 2 [n=36; 8.3%]). There were three grade 3 ILD events (0.7%), zero grade 4 events and three grade 5 events (0.7%) as determined by an independent adjudication committee.

From July 1, 2024 to September 30, 2024, the company has repurchased 13,152,400 shares, representing 0.69% for ¥74,293.69 million. With this, the company has completed the repurchase of 21,527,900 shares, representing 1.13% for ¥119,999.61 million under the buyback announced on April 25, 2024.

Positive results from the pivotal TROPION-Breast01 phase 3 trial showed that datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to investigator's choice of chemotherapy in patients with inoperable or metastatic hormone receptor (HR) positive, HER2 low or negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer previously treated with endocrine-based therapy and at least one systemic therapy. These data, the first of two positive late-breaking presentations (LBA11) from the datopotamab deruxtecan clinical development program, were featured during Presidential Symposium 3 at the European Society for Medical Oncology (#ESMO23) 2023 Congress. Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca. In the dual primary endpoint analysis, datopotamab deruxtecan reduced the risk of disease progression or death by 37% compared to investigator's choice of chemotherapy (hazard ratio [HR]=0.63; 95% confidence interval [CI]: 0.52-0.76; p<0.0001) in patients with HR positive, HER2 low or negative metastatic breast cancer as assessed by blinded independent central review (BICR). Median PFS was 6.9 months in patients treated with datopotamab deruxtecan compared to 4.9 months in those treated with chemotherapy. A consistent benefit in PFS was observed across subgroups. Results also showed a confirmed objective response rate (ORR) of 36.4% in patients treated with datopotamab deruxtecan compared to an ORR of 22.9% in patients treated with chemotherapy. For the dual primary endpoint of overall survival (OS), interim results numerically favored datopotamab deruxtecan over chemotherapy (HR=0.84; 95% CI: 0.62-1.14), however, results did not reach statistical significance at the time of this data cut-off. The trial is ongoing to assess OS. Datopotamab deruxtecan demonstrated a favorable safety profile over chemotherapy with no new safety concerns identified. Grade 3 or higher treatment-related adverse events (TRAEs) occurred in 21% and 45% of patients in the datopotamab deruxtecan and chemotherapy arms, respectively. The most common grade 3 or higher TRAEs were neutropenia (1% vs. 31%), stomatitis (6% vs. 3%), fatigue (2% vs. 2%) and anemia (1% vs. 2%). In the datopotamab deruxtecan arm, the all-grade interstitial lung disease (ILD) rate was low (3%) and the majority of events were low grade. There was one grade 5 ILD event adjudicated as drug- related by an independent committee. The primary cause of death in this case was attributed to disease progression by the treating investigator. After endocrine therapy, the most common prior treatments for patients in the datopotamab deruxtecan and chemotherapy arms, respectively, included one (63% vs. 61%) to two (37% vs. 38%) lines of chemotherapy and CDK4/6 inhibitors (82% vs. 78%). At the July 17, 2023 data cut-off, 93 patients remained on treatment with datopotamab deruxtecan and 39 remained on chemotherapy. Daiichi Sankyo and AstraZeneca have two phase 3 trials evaluating datopotamab deruxtecan in triple negative breast cancer (TNBC). TROPION-Breast02 is comparing datopotamab deruxtecan to chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic TNBC who are not candidates for anti-PD-1/PD-L1 therapy. TROPION-Breast03 is evaluating datopotamab deruxtecan with and without durvalumab versus investigator's choice of therapy in patients with stage 1 to 3 TNBC with residual disease after neoadjuvant therapy.

European Society for Medical Oncology., European Society for Medical Oncology Asia Congress 2024, Dec 06, 2024 through Dec 08, 2024. Venue: Singapore.

Daiichi Sankyo Company, Limited Presents at DPHARM US 2024, Sep-17-2024 . Venue: Philadelphia, PA, Philadelphia, Pennsylvania, United States. Speakers: Yusuf Ghadiali, Executive Director, Global Clinical Operations & Planning.

Daiichi Sankyo Company, Limited and AstraZeneca announced results from the DESTINY-Breast12 phase 3b/4 trial showed that ENHERTU (trastuzumab deruxtecan) demonstrated substantial overall and intracranial clinical activity in a large cohort of patients with HER2 positive metastatic breast cancer who have brain metastases and received no more than two prior lines of therapy in the metastatic setting. Results will be presented as a late-breaking proffered paper presentation (LBA18) at the European Society for Medical Oncology (#ESMO24) and simultaneously published in Nature Medicine. In the primary endpoint analysis of progression-free survival (PFS) assessed by independent central review in patients with brain metastases at baseline (n=263), ENHERTU achieved a 12-month PFS rate of 61.6% (95% confidence interval [CI]: 54.9-67.6). In an additional endpoint analysis in this patient population, ENHERTU demonstrated a central nervous system (CNS) 12-month PFS rate of 58.9% (95% CI: 51.9-65.3). Results were consistent in patients with stable and active brain metastases. Patients with stable brain metastases (n=157) had a 12-month PFS rate of 62.9% (95% CI: 54.0-70.5) and a 12-month CNS PFS rate of 57.8% (95% CI: 48.2-66.1). Patients with active brain metastases (n=106) had a 12-month PFS rate of 59.6% (95% CI: 49.0-68.7) and a 12-month CNS PFS rate of 60.1% (95% CI: 49.2-69.4). In the primary endpoint analysis of confirmed objective response rate (ORR) assessed by independent central review in patients with no brain metastases at baseline (n=241), ENHERTU demonstrated an ORR of 62.7% (95% CI: 56.5-68.8) with 23 complete responses (CR) and 128 partial responses (PR). An additional endpoint analysis of CNS ORR in patients with brain metastases at baseline showed ENHERTU demonstrated a CNS ORR of 62.3% (95% CI: 50.1-74.5; n=38/61) in patients with active brain metastases and 79.2% (95% CI: 70.2-88.3; n=61/77) in patients with stable brain metastases. A post-hoc analysis in patients with active brain metastases showed the CNS ORR was 82.6% (95% CI: 67.1-98.1; n=19/23) in untreated patients and 50.0% (95% CI: 34.1-65.9; n=19/38) in patients with treated/progressing brain metastases. The safety profile of ENHERTU in DESTINY-Breast12 was consistent with previous breast cancer clinical trials with no new safety concerns identified. The safety profile of DESTINY-Breast12 was generally consistent between the brain metastases and non-brain metastases cohorts. The most common grade 3 or higher adverse events occurring in 5% or more of patients in either cohort included neutropenia (16% in brain metastases and 18% in non-brain metastases), fatigue (9% in brain metastases and 10% in non-brain metastases), anemia (7% in brain metastases and 5% in non-brain metastases) and nausea (5% in brain metastases and 5% in non-brain metastases). Interstitial lung disease (ILD) or pneumonitis occurred in 16.0% of patients in the brain metastases cohort and 12.9% of patients in the non-brain metastases cohort as determined by the investigator. In the brain metastases cohort, there were 26 grade 1 events, eight grade 2 events, one grade 3 event, one grade 4 event and six grade 5 events as determined by the investigator. Five ILD or pneumonitis events in the brain metastases cohort were reported by the investigator as co-occurring with opportunistic infection (one grade 4 and four grade 5). In the non-brain metastases cohort, there were 22 grade 1 ILD events, six grade 2 events, zero grade 3 and 4 events, and three grade 5 events as determined by the investigator. Patients in the DESTINY-Breast12 trial received no more than two prior lines of therapy in the metastatic setting. Median duration of follow-up was 15.4 months (range 0.1-30.0) in the brain metastases cohort and 16.1 months (range 0.8-28.4) in the non-brain metastases cohort. A total of 213 patients (118 in the brain metastases cohort and 95 in the non-brain metastases cohort) remained on treatment as of the data cut-off of February 8, 2024.

Daiichi Sankyo announced that it will present new clinical research across its antibody drug conjugate (ADC) portfolio with more than 25 abstracts across multiple types of cancer at the IASLC 2024 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer and the 2024 European Society for Medical Oncology. Data at WCLC and ESMO showcasing Daiichi Sankyo’s progress towards its goal of creating new standards of care for patients with cancer will include six late-breaking presentations, including two back-to-back presentations during Presidential Symposium 1 featuring datopotamab deruxtecan (Dato-DXd) data at WCLC, and the first presentation of clinical data of DS-9606, a CLDN6 directed modified pyrrolobenzodiazepine (PBD) ADC from Daiichi Sankyo’s second ADC platform, at ESMO. Late-breaking data at WCLC to be reported during back-to-back presentations at Presidential Symposium 1 will highlight the first interim results from the NeoCOAST-2 phase 2 platform trial evaluating novel perioperative treatment combinations including one arm studying datopotamab deruxtecan with durvalumab and chemotherapy as neoadjuvant treatment followed by adjuvant treatment with durvalumab in patients with resectable early-stage (IIA to IIIB) non-small cell lung cancer (NSCLC). The second Presidential Symposium 1 presentation will feature results from the application of quantitative continuous scoring (QCS), AstraZeneca’s proprietary computational pathology platform, to measure TROP2 in tissue samples collected in the TROPION-Lung01 phase 3 trial that evaluated datopotamab deruxtecan versus docetaxel in patients with locally advanced or metastatic NSCLC treated with at least one prior line of therapy. Overall survival results from TROPION-Lung01 also will be presented as a late-breaking oral presentation. Other data at WCLC include two oral presentations featuring the interim results from the dose optimization part of the IDeate-Lung01 phase 2 trial of ifinatamab deruxtecan (I-DXd) in patients with pretreated extensive-stage small cell lung cancer and results from the ENHERTU® (trastuzumab deruxtecan) monotherapy arm of the DESTINY-Lung03 phase 1b trial in patients with previously treated HER2 overexpressing unresectable, locally advanced or metastatic NSCLC. A trial-in-progress poster from the NSCLC cohort of a phase 1b trial evaluating the combination of datopotamab deruxtecan and valemetostat, a dual inhibitor of EZH1 and EZH2, in previously treated locally advanced, unresectable or metastatic nonsquamous NSCLC with or without actionable genomic alterations also will be highlighted. At ESMO, additional data in lung cancer being reported include poster presentations featuring a post-hoc analysis of patients with nonsquamous NSCLC by baseline brain metastases status in the TROPION-Lung01 phase 3 trial of datopotamab deruxtecan and intracranial responses seen in the IDeate-Lung01 phase 2 trial of ifinatamab deruxtecan, as well as a trial-in-progress poster featuring the design of the IDeate-Lung03 phase 1b/2 trial of ifinatamab deruxtecan in combination with atezolizumab with or without carboplatin as first-line induction or maintenance therapy in patients with extensive-stage small cell lung cancer. Late-breaking presentations in breast cancer at ESMO will include a proffered paper session featuring the primary results of the DESTINY-Breast12 phase 3b/4 trial evaluating ENHERTU in patients with HER2 positive advanced or metastatic breast cancer with or without brain metastases, and two mini oral sessions highlighting patient reported outcomes and determination of the HER2 low and HER2 ultralow status of tumors from the DESTINY-Breast06 phase 3 trial in patients with HR positive, HER2 low and HER2 ultralow metastatic breast cancer. Two proffered paper sessions will highlight results from the ICARUS-BREAST01 phase 2 study of patritumab deruxtecan (HER3-DXd) in patients with HR positive, HER2 negative advanced breast cancer with disease progression following two or more treatments and the investigator-initiated ERICA phase 2 trial evaluating olanzapine-based triplet antiemetic therapy for prevention of nausea and vomiting in combination with ENHERTU in patients with metastatic breast cancer. A mini oral session will feature a supplementary biomarker analysis from the DAISY phase 2 trial evaluating ENHERTU in three cohorts of patients with HER2 expressing metastatic breast cancer and a poster presentation will report on an exploratory biomarker analysis of ENHERTU in patients with HR positive, HER2 low metastatic breast cancer from the DESTINY-Breast04 phase 3 trial. A poster reporting on exposure-adjusted incidence rates of adverse events from the TROPION-Breast01 phase 3 trial of datopotamab deruxtecan versus chemotherapy in patients with previously treated HR positive, HER2 negative metastatic breast cancer also will be featured. At ESMO, a proffered paper session will highlight preliminary results from a phase 1 trial of DS-9606, a CLDN6 directed modified PBD ADC from Daiichi Sankyo’s second ADC platform, in patients with solid tumors known to express CLDN6. Results from the DESTINY-Gastric03 phase 1b/2 trial evaluating ENHERTU monotherapy or ENHERTU combinations with chemotherapy and/or immunotherapy in patients with HER2 expressing advanced/metastatic gastric or gastroesophageal junction carcinoma also will be presented at a proffered paper session. A mini oral session will feature results from the TROPION-PanTumor03 phase 2 trial of datopotamab deruxtecan in patients with previously treated recurrent endometrial or ovarian cancer. Trial-in-progress poster presentations will highlight the HERTHENA-PanTumor01 phase 2 trial evaluating patritumab deruxtecan in patients with a broad range of solid tumors including bladder, cervical, endometrial, esophageal, gastric, head and neck, melanoma, ovarian, pancreatic and prostate and a phase 1 trial of DS-1471, a CD147 monoclonal antibody, in patients with locally advanced or metastatic solid cancers.

WCLC/ESMO 2024

International Association For The Study Of Lung Cancer, WCLC/ESMO 2024, Sep 17, 2024.

Daiichi Sankyo Company, Limited Presents at ADC & Radiopharmaceuticals Pharma & Biotech Partnering Summit, Sep-09-2024 . Venue: Revere Boston, 200 Stuart Street, Boston, Massachusetts, United States. Speakers: Adrianne Wong, Director, Oncology Search & Evaluation, Global Business Development, Akihiro Furukawa, Director, Research & Technology Search & Evaluation, Global Business Development.

Hanson Wade Limited, ADC & Radiopharmaceuticals Pharma & Biotech Partnering Summit, Sep 09, 2024 through Sep 10, 2024. Venue: Revere Boston, 200 Stuart Street, Boston, Massachusetts, United States.

Daiichi Sankyo Company, Limited Presents at European Society for Medical Oncology Congress (ESMO) 2024, Sep-13-2024 04:10 PM. Venue: Burgos Auditorium – Hall 5, Fira Barcelona Gran Via, Barcelona, Spain. Speakers: F. Suto.

Daiichi Sankyo Company, Limited announced that they will report Q2, 2025 results on Oct 31, 2024