AstraZeneca & Daiichi Sankyo's Enhertu Receives Conditional Nod in China

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been conditionally approved in China for treating adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma after two or more prior treatments.

The NMPA granted provisional approval due to the promising outcomes of the phase II study, DESTINY-Gastric06. Whether a randomized controlled confirmatory clinical trial can show clinical benefit in this population will determine full approval for this indication.

Enhertu is an ADC drug that targets HER2 and was created by Daiichi Sankyo, being developed and marketed by AstraZeneca and Daiichi Sankyo together. In the DESTINY-Gastric06 study, Enhertu showed significant efficacy in Chinese patients with advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma who had received at least two prior treatment regimens including a fluoropyrimidine and platinum agent.

China accounts for over a third of worldwide gastric cancer cases, and approximately 65% of patients are diagnosed with advanced disease. Around 359,000 fresh instances of stomach cancer and 260,000 fatalities were documented in China in 2022. Approximately 20% of gastric cancers worldwide are HER2-positive.

Lin Shen, MD, director of the Department of Gastrointestinal Oncology, Peking University Cancer Hospital, China, said: “HER2-positive metastatic gastric cancer can be particularly aggressive and difficult to treat. Patients often face poor outcomes following disease progression on first-line treatment and subsequent chemotherapy. With the approval of Enhertu, patients in China with HER2-positive metastatic gastric cancer will now have an important anti-HER2 treatment option that has demonstrated clinically meaningful efficacy following progression on previous therapies.”