AKESO (09926.HK): Phase III Results for Ivonescimab in First-Line Biliary Tract Cancer at ESMO

NewTimeSpace News: On 26 October 2026, Akeso, Inc. (stock code: 9926) published a voluntary announcement that the HARMONi-GI1/AK112-309 study was selected as a Late-Breaking Abstract (LBA) for an oral presentation at the Presidential Symposium of the 2026 Congress of the European Society for Medical Oncology (ESMO), presented by the principal investigator, Academician Zhou Jian (周俭), President of Zhongshan Hospital affiliated to Fudan University.

The study is a randomised, controlled, double-blind, registrational Phase III trial evaluating ivonescimab plus chemotherapy versus durvalumab plus chemotherapy in the first-line treatment of advanced biliary tract cancer, enrolling 682 subjects. In August 2026, a prespecified interim analysis assessed by the independent data monitoring committee showed that the study met its primary overall survival (OS) endpoint, as well as all key secondary endpoints of progression-free survival (PFS) and objective response rate (ORR).

In the intention-to-treat population, median OS was 14.9 months with ivonescimab versus 12.1 months with durvalumab, with a hazard ratio of 0.75 (95% CI 0.61-0.92), a 25% reduction in the risk of death (P=0.0031). The 12-month OS rates were 59.7% versus 50.7% and the 18-month OS rates 44.0% versus 32.5%. Median PFS was 8.4 versus 5.8 months (HR 0.61; 95% CI 0.51-0.72), a 39% reduction in the risk of disease progression or death (P<0.0001); ORR was 53.8% versus 32.5%, an absolute difference of 21.3 percentage points (P<0.0001).

The ivonescimab arm showed a favourable overall safety profile with longer treatment exposure; the most common adverse events of all grades and of grade 3/4 were haematological, with no new safety signals identified. Ivonescimab plus chemotherapy for first-line biliary tract cancer has been proposed by the NMPA for priority review. Overseas partner Summit Therapeutics has collaborated with the US ECOG-ACRIN Cancer Research Group to launch the global multicentre registrational Phase II/III EA2251 study comparing the regimen with pembrolizumab or durvalumab plus chemotherapy.