Key insights
- Takeda Pharmaceutical's experimental drug arcotatug tavatecan (TAK-921) demonstrated positive results in a Phase 3 gastric cancer trial, meeting dual primary endpoints for overall survival and progression-free survival. The drug showed significant improvements compared to treatment of physician's choice. Takeda plans regulatory filings in Japan and has an accepted New Drug Application in China. These results support potential future global trials and commercialization.
Takeda Pharmaceutical (4502 / NYSE: TAK) announced that its experimental drug arcotatug tavatecan (TAK-921) met dual primary endpoints of overall survival (OS) and progression-free survival (PFS) in a Phase 3 study of patients with previously treated, CLDN18.2-positive advanced gastric or gastroesophageal junction adenocarcinoma.
Results from the G-HOPE-001 study (NCT06238843) were presented at the 2026 European Society for Medical Oncology Congress. The trial enrolled 464 participants across Japan and China, randomized to receive arcotatug tavatecan or treatment of physician’s choice (TPC), which included irinotecan, paclitaxel, or trifluridine/tipiracil.
In the second interim analysis, with a data cutoff of September 3, 2026, median OS was 10.2 months with arcotatug tavatecan versus 6.9 months with TPC (HR=0.57 [95% CI: 0.45–0.73], P<0.0001). Median PFS per independent radiological review was 7.1 months versus 3.1 months with TPC (HR=0.45 [95% CI: 0.35–0.58]). The confirmed objective response rate was 37.4% with arcotatug tavatecan versus 7.7% with TPC.
The rate of Grade ≥3 treatment-related adverse events was 47.4% in the arcotatug tavatecan arm versus 55.9% with TPC. One treatment-related fatal adverse event, reported as sudden death of unknown cause, occurred in the arcotatug tavatecan arm.
Takeda said the data will support a planned regulatory filing in Japan. In China, Innovent’s New Drug Application for arcotatug tavatecan has been accepted with Priority Review by the National Medical Products Administration. Takeda holds rights to develop, manufacture, and commercialize arcotatug tavatecan worldwide outside of greater China under a license and collaboration agreement with Innovent.
Arcotatug tavatecan has not been approved by the U.S. Food and Drug Administration or any other regulatory authority. Takeda said it plans to initiate global Phase 3 trials in gastric and pancreatic cancer.
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