AstraZeneca, Daiichi Sankyo announces Enhertu approved in China

AstraZeneca (AZN) and Daiichi Sankyo’s (DSNKY) Enhertu has received conditional approval in China as a monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer, NSCLC, whose tumours have activating HER2, ERBB2, mutations and who have received a prior systemic therapy. The conditional approval by the National Medical Products Administration, NMPA, was based on the positive results of the DESTINY-Lung02 and DESTINY-Lung05 Phase II trials. Full approval for this indication will depend on the clinical benefit of a confirmatory trial. In DESTINY-Lung02, which included patients from Japan, Korea and Taiwan, patients with previously treated HER2-mutant metastatic NSCLC treated with Enhertu showed a confirmed objective response rate of 49.0%, as assessed by blinded independent central review. Median duration of response was 16.8 months. Median progression-free survival was 9.9 months and median overall survival was 19.5 months. In DESTINY-Lung05, Enhertu demonstrated a consistent clinically meaningful response in patients in China with previously treated HER2-mutant metastatic NSCLC. Treatment with Enhertu resulted in a confirmed ORR of 58.3%, as assessed by independent central review.