ZN-A-1041

HERTHENA-Lung01 pivotal data demonstrate potential of patritumab deruxtecan in patients with EGFR-mutated non-small cell lung cancer TROPION-Lung04 late-breaking results continue to show promise of datopotamab deruxtecan-based combinations in patients with non-small cell lung cancer without actionable genomic alterations Investor meeting to discuss WCLC presentations BASKING RIDGE, N.J.--(BUSINESS WIRE)-- Daiichi Sankyo (TSE: 4568) will present new clinical research across its DXd antibody drug conjugate (ADC) portfolio in non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) at the IASLC 2023 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC23) being held September 9-12, 2023. Data at WCLC showcasing the company’s progress in creating new standards of care for patients with lung cancer will include primary results of the HERTHENA-Lung01 pivotal phase 2 trial evaluating patritumab deruxtecan (HER3-DXd) in patients with EGFR-mutated NSCLC and late-breaking interim results of the TROPION-Lung04 phase 1b trial evaluating datopotamab deruxtecan (Dato-DXd) in combination with durvalumab with or without carboplatin in patients with metastatic NSCLC without actionable genomic alterations. Data from both trials will be presented for the first time as oral presentations. Updates from other ongoing trials including the primary analysis of the DESTINY-Lung02 phase 2 trial evaluating ENHERTU in HER2 mutant metastatic NSCLC and updated data from a phase 1/2 trial evaluating ifinatamab deruxtecan (I-DXd) in refractory SCLC also will be highlighted as oral presentations. “Data at WCLC from four of our DXd antibody drug conjugates in populations across several different subtypes of non-small cell lung cancer and small cell lung cancer continue to demonstrate Daiichi Sankyo’s commitment to creating new standards of care for these patients,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “We look forward to presenting for the first time important data from our pivotal HERTHENA-Lung01 trial of patritumab deruxtecan in patients with EGFR-mutated metastatic non-small cell lung cancer and TROPION-Lung04 evaluating datopotamab deruxtecan in combination with durvalumab with or without chemotherapy in patients with metastatic non-small cell lung cancer.” Trials-in-progress poster presentations of the TROPION-Lung08 and AVANZAR phase 3 trials evaluating datopotamab deruxtecan-based combinations in patients with first line metastatic NSCLC and a phase 2 trial evaluating ifinatamab deruxtecan in patients with previously treated extensive-stage SCLC also will be presented. Daiichi Sankyo will hold a virtual conference call for investors on Monday, September 11, 2023 from 7:00 to 8:30 pm EDT / Tuesday, September 12, 2023 from 8:00 to 9:30 am JST. Executives from Daiichi Sankyo will provide an overview of the WCLC research data and address questions. Highlights of data from Daiichi Sankyo’s DXd ADC portfolio at 2023 WCLC include: Presentation Title Lead Author Session Presentation Time Patritumab Deruxtecan (HER3-DXd) Patritumab deruxtecan (HER3-DXd) in EGFR-mutated NSCLC following EGFR TKI and platinum-based chemotherapy: HERTHENA-Lung01 H.A. Yu OA05.03 Oral Presentation Sunday, September 10 3:02 - 3:12 pm SGT Clinical outcomes of real-world treatment for metastatic EGFRm NSCLC after osimertinib and platinum-based chemotherapy J. Patel P2.31-10 Poster Presentation Monday, September 11 6:00 - 7:30 pm SGT Datopotamab Deruxtecan (Dato-DXd) Datopotamab deruxtecan (Dato-DXd) + durvalumab ± carboplatin in advanced/metastatic NSCLC: initial results from phase 1b TROPION-Lung04 K.P. Papadopoulous OA05.06 LBA Oral Presentation Sunday, September 10 3:32 - 3:42 pm SGT TROPION-Lung08: datopotamab deruxtecan plus pembrolizumab in untreated advanced/metastatic non-small cell lung cancer (NSCLC) C. Zhou P2.08-01 Poster Presentation Monday, September 11 6:00 - 7:30 pm SGT AVANZAR: Phase III Study of datopotamab deruxtecan (Dato-DXd) + durvalumab + carboplatin as 1L treatment of advanced/metastatic NSCLC C. Aggarwal P2.04-02 Poster Presentation Monday, September 11 6:00 - 7:30 pm SGT ENHERTU (trastuzumab deruxtecan; T-DXd) Trastuzumab deruxtecan in patients with HER2 mutant metastatic non-small cell lung cancer: primary results of DESTINY-Lung02 P. Jänne MA13.10 Mini Oral Presentation Monday, September 11 4:25 - 4:30 pm SGT Ifinatamab Deruxtecan (I-DXd) Ifinatamab deruxtecan (I-DXd; DS-7300) in patients with refractory SCLC: a subgroup analysis of a phase 1/2 study M. Johnson OA05.05 Oral Presentation Sunday, September 10 3:22 - 3:32 pm SGT A phase 2 study of ifinatamab deruxtecan (I-DXd; DS-7300) in patients with previously treated ES-SCLC C. Rudin P2.16-06 Poster Presentation Monday, September 11 6:00 - 7:30 pm SGT About the DXd ADC Portfolio of Daiichi Sankyo The DXd ADC portfolio of Daiichi Sankyo currently consists of five ADCs in clinical development across multiple types of cancer. The company’s clinical trial stage DXd ADCs include ENHERTU, a HER2 directed ADC, and datopotamab deruxtecan (Dato-DXd), a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca; and patritumab deruxtecan (HER3-DXd), a HER3 directed ADC. Two additional ADCs including ifinatamab deruxtecan (I-DXd; DS-7300), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd; DS-6000), a CDH6 directed ADC, are being developed through a strategic early-stage research collaboration with Sarah Cannon Research Institute. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, each ADC targets and delivers a cytotoxic payload inside cancer cells that express a specific cell surface antigen. 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. Datopotamab deruxtecan, ifinatamab deruxtecan, patritumab deruxtecan and raludotatug deruxtecan are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit .