Enhertu approved in China for patients with previously treated HER2-positive advanced or metastatic gastric cancer – AstraZeneca + Daiichi Sankyo

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has received conditional approval in China as a monotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received two or more prior treatment regimens.

The conditional approval by the National Medical Products Administration (NMPA) was based on the positive results of the DESTINY-Gastric06 Phase II trial. Full approval for this indication will depend on whether a randomised controlled confirmatory clinical trial can demonstrate clinical benefit in this population.

Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

In the DESTINY-Gastric06 trial, Enhertu demonstrated clinically meaningful efficacy in patients in China with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma previously treated with two or more prior regimens including a fluoropyrimidine agent and a platinum agent.

More than one third of the global cases of gastric cancer occur in China, with about 65% of patients presenting with advanced disease at the time of diagnosis. Approximately 359,000 new cases of gastric cancer and 260,000 deaths were reported in China in 2022. Roughly one in five gastric cancers globally are HER2-positive.