ENHERTU approved in China as first HER2 directed therapy for patients with HER2 mutant metastatic non-small cell lung cancer

CAR-T Digest - August 2020

14 Oct 2024: ENHERTU approved in China as first HER2 directed therapy for patients with HER2 mutant metastatic non-small cell lung cancer

Daiichi Sankyo and AstraZeneca’s ENHERTU has received conditional approval in China for treating adult patients with unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC) with HER2 mutations after prior systemic therapy
The approval is based on the results from the DESTINY-Lung02 and DESTINY-Lung05 phase 2 trials, which demonstrated significant tumor responses in patients with HER2 mutant NSCLC
In the DESTINY-Lung02 trial, ENHERTU showed a confirmed overall response rate (ORR) of 49.0%, with a median duration of response of 16.8 months
DESTINY-Lung05 results indicated a confirmed ORR of 58.3% among patients in China, reinforcing the efficacy seen in the global trial
This approval is significant as it introduces the first HER2-directed therapy for HER2 mutant metastatic NSCLC in China, emphasizing the need for testing predictive biomarkers for optimal treatment