Takeda’s TAK-921 improves overall survival in Phase 3 gastric cancer trial
TAK•Takeda said arcotatug tavatecan improved overall survival and delayed disease progression versus physician-selected treatments in the Phase 3 G-HOPE-001 trial of previously treated patients with CLDN18.2-positive advanced gastric cancer. The results support a planned regulatory filing in Japan.
1. Trial results
Arcotatug tavatecan met both primary endpoints in the Phase 3 G-HOPE-001 trial, improving overall survival and delaying disease progression compared with physician-selected treatments. The trial enrolled patients with previously treated CLDN18.2-positive advanced gastric cancer, and the drug’s safety profile was generally manageable.
2. Regulatory plans
Results were presented at the 2026 European Society for Medical Oncology Congress. Takeda plans a regulatory filing in Japan, while Innovent’s application in China has received priority review. Planned global Phase 3 trials will evaluate the drug in gastric and pancreatic cancer.
