Organizations
- Akeso
- Summit Therapeutics
The HARMONi-GI1 trial tested first-line ivonescimab in advanced biliary tract cancer. The companies reported a statistically significant overall-survival benefit and said detailed efficacy and safety data will be presented later.
What happened
- The China-based Phase 3 HARMONi-GI1 trial compared ivonescimab plus chemotherapy with durvalumab plus chemotherapy in first-line advanced biliary tract cancer.
- The companies said the study met its primary overall-survival endpoint.
- Numerical efficacy and safety results have not yet been released.
Why it matters
The result extends ivonescimab’s Phase 3 record beyond lung cancer and sets up a direct data comparison with an established immunotherapy regimen once full results arrive.
Key details
- Trial
- HARMONi-GI1 (NCT06591520)
- Setting
- First-line advanced biliary tract cancer in China
- Primary endpoint
- Overall survival
What to watch
- The full efficacy and safety data, subgroup results, and plans for development outside China.
Event chronology
How the story developed
Topline result
Summit and Akeso reported that HARMONi-GI1 met its overall-survival endpoint.
Evidence ledger
Sources behind this brief
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