Enhertu® Demonstrated Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival as First-Line Treatment of Patients with HER2 Mutant Advanced Non-Small Cell Lung Cancer in DESTINY-Lung04 Phase 3 Trial
Daiichi Sankyo and AstraZeneca's Enhertu is the first and only HER2 directed medicine to improve progression-free survival over global standard of care in a phase 3 trial in this setting
Data to be presented at an upcoming medical meeting and shared with global regulatory authorities
TOKYO, August 17, 2026--Positive topline results from the DESTINY-Lung04 phase 3 trial showed Enhertu® (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus global standard of care (platinum-pemetrexed doublet chemotherapy plus pembrolizumab) as first-line treatment of patients with unresectable, locally advanced or metastatic HER2 mutant non-squamous non-small cell lung cancer (NSCLC). The trial will continue as planned to evaluate secondary endpoints including overall survival.
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/NYSE: AZN).
Global standard of care for patients with HER2 mutant NSCLC in the first-line metastatic setting is a combination of immunotherapy and platinum-based chemotherapy.1,2,3 However, many patients do not respond to first-line treatment and experience disease progression, underscoring the need for additional treatment options.3,4,5,6,7 Approximately 2% to 4% of patients with NSCLC have tumors with a HER2 mutation.8,9,10,11
"Enhertu is already established as the first and only antibody drug conjugate for the second-line treatment of HER2 mutant metastatic non-small cell lung cancer," said John Tsai, MD, Global Head of R&D, Daiichi Sankyo. "The positive results seen in DESTINY-Lung04 show that treatment with Enhertu in the first-line setting delays disease progression compared to the global standard of care, highlighting its potential to improve outcomes for patients earlier in the treatment of metastatic disease."
"Our oncology pipeline continues to advance with DESTINY-Lung04 becoming the first phase 3 trial to demonstrate a progression-free survival benefit versus the global standard of care in this first-line setting, supporting the potential for Enhertu to move earlier in the treatment of HER2 mutant non-small cell lung cancer," said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology Hematology R&D, AstraZeneca. "This aggressive lung cancer often affects younger patients and has historically had limited first-line targeted treatment options, making these positive results an important step forward in bringing additional effective therapies to patients at metastatic diagnosis when there is the greatest opportunity to improve outcomes."