Summit Therapeutics announced that its partner, Akeso, Inc., reported positive topline results from the Phase III HARMONi-GI1 study. The trial, conducted in China, found that ivonescimab plus chemotherapy demonstrated statistically significant superiority in overall survival compared to durvalumab plus chemotherapy for the first-line treatment of advanced biliary tract cancer.
Key Details
- Primary Endpoint: The study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in overall survival (OS) for the ivonescimab regimen at a pre-specified interim analysis.
- Secondary Endpoints: Key secondary endpoints, including progression-free survival (PFS) and objective response rate (ORR), were also successfully met.
- Study Context: The HARMONi-GI1 study was sponsored and conducted by Akeso in China. Ivonescimab (known as SMT112 in Summit's territories) is not yet approved by regulatory authorities in the United States or Europe.