Data from the Phase III HARMONi-GI1 trial, conducted in China and sponsored by Akeso, Inc., featuring the novel, potential first-in-class investigational bispecific antibody ivonescimab, will be featured as part of the Presidential Symposium II at the European Society for Medical Oncology 2026 Congress (ESMO 2026) which takes place October 23–27, 2026, in Madrid, Spain. The presentation will take place on Sunday, October 25 during the Presidential Symposium from 4:30pm – 6:15pm CET (11:30am – 1:15pm EDT).

The HARMONi-GI1 study is evaluating ivonescimab plus chemotherapy compared with durvalumab plus chemotherapy as a first-line treatment for patients with advanced biliary tract cancer (BTC). HARMONi-GI1 is a single-region, multi-center, Phase III study conducted in China and sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed by Akeso.

On August 25, 2026, Akeso announced topline results from HARMONi-GI1. Akeso reported that, at a pre-specified interim analysis, the ivonescimab-based regimen achieved statistically significant and clinically meaningful superiority in the primary endpoint of overall survival (OS) compared to the durvalumab-based regimen. The study also met the key secondary endpoints of progression-free survival (PFS) and objective response rate (ORR).