Daiichi Sankyo Doses First Patient in DESTINY-Lung06 Phase 3 Trial of ENHERTU® in NSCLC (TSE:4568)

October 31, 2025. — Leads & Copy — The first patient has been dosed in the DESTINY-Lung06 phase 3 trial evaluating ENHERTU® (trastuzumab deruxtecan) plus pembrolizumab versus pembrolizumab, platinum-based chemotherapy and pemetrexed as a first-line treatment in patients with unresectable, locally advanced or metastatic HER2 overexpressing and PD-L1 TPS <50% non-squamous non-small cell lung cancer (NSCLC).

ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

Abderrahmane Laadem, MD, Head, Late-Stage Oncology Clinical Development, Daiichi Sankyo, said DESTINY-Lung06 is evaluating a targeted treatment strategy for patients with HER2 overexpressing metastatic non-squamous non-small cell lung cancer with low PD-L1 expression and that the trial is evaluating whether replacing traditional chemotherapy with ENHERTU and combining it with standard of care immunotherapy could potentially improve outcomes for patients in the first-line metastatic setting.

DESTINY-Lung06 will enroll approximately 686 patients across multiple sites in Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov.

Lung cancer is the most common cancer globally and is the leading cause of cancer-related death in both men and women. More than 2.48 million lung cancer cases were diagnosed in 2022, with 1.8 million deaths globally.6 NSCLC is the most common type of lung cancer, accounting for approximately 85% of cases.

ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

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.

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.

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. Please see accompanying full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

For more information, please visit www.daiichisankyo.com.

Source: Daiichi Sankyo

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