Innovent Biologics and Takeda reported longer median survival with their experimental drug in a Phase 3 trial of previously treated, CLDN18.2-positive advanced gastric or gastroesophageal junction adenocarcinoma.
The companies said the G-HOPE-001 study met its primary endpoints of overall survival and progression-free survival. In Takeda's second interim analysis, patients receiving arcotatug tavatecan had median overall survival of 10.2 months, compared with 6.9 months for those assigned to physician-selected treatment. The reported hazard ratio was 0.57 (95% confidence interval, 0.45–0.73; P<0.0001), with data through Sept. 3, 2026.
Takeda said findings from two interim analyses were presented at the 2026 European Society for Medical Oncology Congress.
For progression-free survival, Takeda reported medians of 5.5 months with the drug and 2.9 months with physician-selected treatment at the first interim analysis, based on data through Feb. 13. Its second interim analysis included a separate assessment by an independent radiological review committee, which put the medians at 7.1 months and 3.1 months. Innovent reported confirmed objective response rates of 37.4% and 7.7%, respectively.
Takeda said 464 participants enrolled in the randomized, open-label study in China and Japan. The comparison group received irinotecan, paclitaxel or trifluridine/tipiracil. Treatment-related adverse events of Grade 3 or higher affected 47.4% of patients in the drug group and 55.9% in the comparison group. Takeda reported one fatal treatment-related event in the drug group, which it characterized as an unexplained sudden death.
Arcotatug tavatecan is an investigational antibody-drug conjugate that targets CLDN18.2 and carries an exatecan payload. Innovent uses the code IBI343, while Takeda calls it TAK-921. Innovent said China's National Medical Products Administration accepted its application for Priority Review. Takeda expects to use the trial results in a Japan filing and plans global Phase 3 studies in gastric and pancreatic cancer; it has not given a timetable.
