Akeso (09926) announced that its PD-1/VEGF bispecific antibody ivonescimab, combined with chemotherapy, achieved the primary endpoint of overall survival (OS) in the Phase III HARMONi-GI1/AK112-309 study for first-line treatment of advanced biliary tract cancer (BTC).

The randomized, double-blinded, multicenter trial enrolled 682 patients and compared ivonescimab plus chemotherapy against durvalumab plus chemotherapy. An Independent Data Monitoring Committee confirmed that interim analysis met the pre-specified threshold for a statistically significant and clinically meaningful OS benefit. All key secondary endpoints—progression-free survival (PFS) and objective response rate (ORR)—were also met. Detailed efficacy and safety data will be presented at a forthcoming international conference.

HARMONi-GI1 marks ivonescimab’s first positive Phase III result in a gastrointestinal tumor, following four prior successful Phase III read-outs in lung cancer. Ivonescimab has already secured Chinese regulatory approvals for three non-small cell lung cancer (NSCLC) indications since 2024, and all are listed on the National Reimbursement Drug List.

Akeso is currently running more than 60 Phase II/III trials covering over 40 indications, with 16 registrational studies underway, reflecting the company’s strategy to expand ivonescimab’s clinical footprint across multiple solid tumors.