Ivonescimab Biliary Tract Cancer Survival Data Selected for ESMO 2026 Presidential Symposium

Akeso announced that overall-survival results from the Phase III HARMONi-GI1 trial of ivonescimab plus chemotherapy versus durvalumab plus chemotherapy in first-line advanced biliary tract cancer were selected as an ESMO 2026 Late-Breaking Abstract.

The data will be presented in the Presidential Symposium as abstract LBA8 on October 25, 2026, in Madrid. Detailed numerical results remain under embargo until the presentation.

Akeso previously reported that HARMONi-GI1 met its primary overall-survival endpoint with statistically significant and clinically meaningful superiority for the ivonescimab regimen. Key secondary endpoints—progression-free survival and objective response rate—were also met.

The China-conducted trial randomized 682 patients, according to trade-press reports. It is described as the first known Phase III study in advanced biliary tract cancer to demonstrate overall-survival superiority over an anti-PD-(L)1 plus chemotherapy regimen.

Nearly 30 Akeso clinical studies are scheduled for presentation at ESMO 2026, including one late-breaking abstract and two oral presentations. Ivonescimab will feature in 12 presentations.

The announcement is potentially important for Akeso and partner Summit Therapeutics because it provides a high-profile clinical validation opportunity for ivonescimab, a PD-1/VEGF bispecific antibody, in a new tumor type. However, the findings are based on a single-region China study, and the full magnitude of benefit and safety profile have not yet been disclosed.