Akeso, Summit Therapeutics to Test Ivonescimab in Phase II/III Biliary Tract Cancer Trial

Akeso Inc. (9926.HK) said partner Summit Therapeutics (SMMT) has entered a clinical trial collaboration with ECOG-ACRIN Cancer Research Group to evaluate ivonescimab in a registration-enabling Phase II/III study in biliary tract cancer. The study, designated EA2251, will test ivonescimab plus chemotherapy against immunotherapy-based regimens including Merck's pembrolizumab or durvalumab plus chemotherapy in previously untreated patients with advanced disease. It marks the seventh international registrational Phase II/III trial for ivonescimab and the second Phase III registrational study in biliary tract cancer. The collaboration follows positive results from Akeso's Phase III HARMONi-GI1 study in China, which showed a statistically significant and clinically meaningful improvement in overall survival for ivonescimab plus chemotherapy versus durvalumab plus chemotherapy in first-line biliary tract cancer. U.S. trial site activations are expected to begin in the fourth quarter of 2026. Ivonescimab is a bispecific antibody targeting PD-1 and VEGF. Akeso has licensed U.S., Canadian, European, Japanese and other international rights to Summit Therapeutics. Shares of 9926.HK closed Wednesday at $92.80, up 1.53%.