Trastuzumab Deruxtecan Granted Priority Review in China for HER2-Positive Advanced Gastric Cancer

On June 10, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced that Trastuzumab Deruxtecan (T-DXd, DS-8201a) is proposed to be granted priority review for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received one prior treatment regimen.

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In the Phase II DESTINY-Gastric01 trial, DS-8201 significantly improved response rates and overall survival in patients with HER2-positive gastric adenocarcinoma (GC) or gastroesophageal junction (GEJ) adenocarcinoma. The trial enrolled 125 patients treated with DS-8201, showing an objective response rate (ORR) of 51%, a median duration of response (DOR) of 11.3 months, and a disease control rate (DCR) of 86%.

The Phase III DESTINY-Gastric04 study evaluated the efficacy and safety of Trastuzumab Deruxtecan(6.4 mg/kg) versus ramucirumab plus paclitaxel as second-line treatment for patients with HER2-positive unresectable and/or metastatic gastric or GEJ adenocarcinoma. Results showed that, as of October 24, 2024, the trastuzumab deruxtecan group demonstrated a significantly prolonged overall survival (OS) (14.7 months vs. 11.4 months, HR=0.70, P=0.0044) and progression-free survival (PFS) (6.7 months vs. 5.6 months). The ORR was also higher (44.3% vs. 29.1%), as was the DCR (91.9% vs. 75.9%).

Trastuzumab deruxtecan (formerly DS-8201), an antibody–drug conjugate consisting of a humanized anti-HER2 monoclonal antibody linked to a topoisomerase I inhibitor payload through a tetrapeptide-based cleavable linker, has been approved for the treatment of patients with metastatic HER2-positive breast cancer. Unlike many other approved HER2-targeted therapies, trastuzumab deruxtecan can also effectively target tumor cells that express low levels of HER2 and can deliver its potent cytotoxic payload (drug-to-antibody ratio, 8:1) through the bystander effect to neighboring tumor cells heterogeneously expressing HER2.

At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.

Phone Number:4008803716

Email:myimmnet@163.com

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Post time: Jun-19-2025