AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568)’s co-developed antibody drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), has received conditional approval from China’s National Medical Products Administration (NMPA) for the treatment of adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors exhibit activating HER2 (ERBB2) mutations and who have undergone prior systemic therapy.
This marks Enhertu’s fourth indication approval in China, following its previous approvals for the treatment of unresectable or metastatic HER2 positive breast cancer, HER2 low expressed breast cancer, and locally advanced or metastatic HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ). The ADC is now the first and only ADC approved in China for the treatment of HER2-mutant advanced NSCLC.
The conditional approval was supported by the positive outcomes of the DESTINY-Lung02 and DESTINY-Lung05 Phase II trials. DESTINY-Lung02 included patients from Japan, Korea, and Taiwan (China) and demonstrated a confirmed objective response rate (ORR) of 49.0% for patients with previously treated HER2-mutant metastatic NSCLC treated with Enhertu, as assessed by blinded independent central review (BICR). The median duration of response (DoR) was 16.8 months, with a median progression-free survival (PFS) of 9.9 months and a median overall survival (OS) of 19.5 months.
In the Chinese trial, DESTINY-Lung05, Enhertu showed a consistent and meaningful response with a confirmed ORR of 58.3% in patients with previously treated HER2-mutant metastatic NSCLC, as assessed by independent central review (ICR). The safety profile of Enhertu in both trials was found to be similar and generally consistent with previous clinical trials, raising no new safety concerns.- Flcube.com
