AstraZeneca and Daiichi Sankyo announced that Enhertu met its primary endpoint in the DESTINY-Lung04 Phase III trial. The study evaluated Enhertu as a first-line treatment for advanced non-small cell lung cancer (NSCLC) with a HER2 mutation.
Enhertu demonstrated statistically significant and clinically meaningful improvements in progression-free survival compared to chemotherapy and immunotherapy. This result marks the first HER2-directed therapy to show such benefits in a Phase III trial for this setting.
The drug’s safety profile remained consistent with previous findings, with no new concerns identified. The companies will share detailed results at an upcoming medical conference and with global regulatory authorities. The trial continues to monitor secondary endpoints, including overall survival.