ENHERTU (trastuzumab deruxtecan) - (DESTINY-Lung04)

August 17, 2026: AstraZeneca (NYSE: AZN) and Daiichi Sankyo reported positive high-level results from the Phase III DESTINY-Lung04 trial of ENHERTU (fam-trastuzumab deruxtecan-nxki) in 1st-line unresectable, locally advanced or metastatic HER2-mutant non-squamous NSCLC.

ENHERTU showed a statistically significant and clinically meaningful improvement in progression-free survival versus global standard of care of platinum-pemetrexed chemotherapy plus pembrolizumab. The trial will continue to assess secondary endpoints including overall survival. Safety was generally consistent with ENHERTU’s known profile, with no new safety concerns identified.

DESTINY-Lung04 is a global, randomized, open-label Phase III study comparing ENHERTU 5.4 mg/kg against platinum-pemetrexed plus pembrolizumab in patients with HER2 exon 19 or 20-mutant disease; 454 patients were enrolled across Asia, Europe and North America. The primary endpoint is blinded independent central review-assessed PFS.

The companies said the data will be presented at a forthcoming medical meeting and shared with global regulatory authorities. ENHERTU is currently approved for previously treated metastatic NSCLC with activating HER2 mutations, with continued approval in some regions contingent on confirmatory benefit.