Akeso announces Phase II/III trial of ivonescimab in first-line biliary tract cancer
SMMT•Akeso announced that partner Summit Therapeutics and ECOG-ACRIN will collaborate on a Phase II/III trial comparing ivonescimab plus chemotherapy with pembrolizumab or durvalumab plus chemotherapy in advanced biliary tract cancer. US site activations are expected in the fourth quarter of 2026.
1. Trial design
The EA2251 study will evaluate ivonescimab in first-line treatment of advanced biliary tract cancer. It is ivonescimab’s seventh international registrational trial and its second in biliary tract cancer; US site activations are expected in the fourth quarter of 2026.
2. Earlier trial results
A China-based Phase III trial, HARMONi-GI1, showed a clinically meaningful survival benefit for ivonescimab with chemotherapy versus durvalumab with chemotherapy. Detailed results are scheduled for presentation at the European Society for Medical Oncology Congress on October 25, 2026.
