Ivonescimab Demonstrates Statistically Significant Overall Survival Benefit in Advanced Biliary Tract Cancer

Akeso Inc., a company based in China, has announced positive results from its Phase III clinical trial evaluating ivonescimab plus chemotherapy against durvalumab plus chemotherapy as a first-line treatment for patients with advanced biliary tract cancer (BTC). The study, known as HARMONi-GI1, demonstrated statistically significant and clinically meaningful superiority in the primary endpoint of overall survival (OS) compared to the durvalumab-based regimen. This marks the first Phase III study in advanced BTC to demonstrate OS superiority versus anti-PD-(L)1 plus chemotherapy.

Ivonescimab is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. The study enrolled patients in China and was sponsored by Akeso. Detailed results from this trial are expected to be presented at an upcoming medical congress and published in a peer-reviewed journal.