AstraZeneca and Daiichi Sankyo's ENHERTU demonstrated a median progression-free survival of 14.3 months as first-line therapy in patients with HER2-mutant advanced non-small cell lung cancer in the DESTINY-Lung04 Phase III trial, a six-month improvement over pembrolizumab plus chemotherapy. In the primary endpoint of PFS, ENHERTU monotherapy significantly reduced the risk of disease progression or death by 37.0% versus pembrolizumab plus chemotherapy, with a hazard ratio of 0.63 and a p-value below 0.0001, compared with a median PFS of 8.3 months for the standard-of-care arm. Objective response rate was 70.0% with ENHERTU versus 44.5% with pembrolizumab plus chemotherapy, and median duration of response was 13.4 months versus 9.7 months. The trial enrolled 454 patients across Asia, Europe and North America, and results were presented during the Presidential Symposium at the IASLC 2026 World Conference on Lung Cancer in Seoul, South Korea. ENHERTU is the first HER2-directed therapy to delay disease progression over standard of care in a Phase III trial in this setting, and its safety profile was generally consistent with its known profile with no new safety concerns identified.
Daiichi Sankyo Company, LimitedEnhertu, co-developed by Daiichi Sankyo, showed a 37% reduction in progression risk in first-line HER2-mutant NSCLC in the DESTINY-Lung04 Phase III trial.
AstraZeneca PLCEnhertu, co-developed by AstraZeneca, cut progression risk 37% in first-line HER2-mutant NSCLC in the DESTINY-Lung04 Phase III trial.
