AKESO(09926): Ivonescimab plus chemotherapy versus durvalumab plus chemotherapy as first-line treatment for advanced biliary tract cancerresults of the HARMONi-GI1 study prominently published at 2026 ESMO

AKESO (09926) announced that HARMONi-GI1/AK112-309 was selected as a Late-Breaking Abstract (LBA) for an oral presentation at the Presidential Forum of the 2026 ESMO Congress, presented by the principal investigator, Academician Zhou Jian, President of Zhongshan Hospital Affiliated to Fudan University. HARMONi-GI1/AK112-309 (CTR20243164) is a randomized, controlled, double-blind, registrational Phase III clinical study evaluating ivonescimab plus chemotherapy versus durvalumab plus chemotherapy as first-line treatment for advanced biliary tract cancer, enrolling a total of 682 subjects. In August 2026, a prespecified interim analysis assessed by the Independent Data Monitoring Committee (IDMC) showed that the study met the primary endpoint of overall survival (OS), achieving statistically significant and clinically meaningful positive results; the study also met all key secondary endpoints of progression-free survival (PFS) and objective response rate (ORR). The trial results showed: In the ITT population, The median OS (mOS) was 14.9 months in the ivonescimab group versus 12.1 months in the durvalumab group, with an OS HR of 0.75 (95% CI: 0.610.92), representing a 25% reduction in the risk of death (P=0.0031). The 12-month OS rates were 59.7% vs 50.7% and the 18-month OS rates were 44.0% vs 32.5% for the ivonescimab group vs the durvalumab group, respectively. The median PFS (mPFS) was 8.4 months in the ivonescimab group versus 5.8 months in the durvalumab group, with a PFS HR of 0.61 (95% CI: 0.510.72), representing a 39% reduction in the risk of disease progression or death (P<0.0001). The ORR was 53.8% vs 32.5% for the ivonescimab group vs the durvalumab group, respectively, with an absolute difference () of 21.3% (P<0.0001). The ivonescimab group showed a favorable overall safety profile and longer treatment exposure; the most common adverse events of all grades and grade 3/4 were hematologic toxicities, and no new safety signals were identified. Biliary tract malignancies are highly heterogeneous malignancies originating from the bile ducts and gallbladder, with a poor prognosis. PD-1/L1 combined with chemotherapy is the international first-line treatment regimen for advanced biliary tract cancer, but the overall survival benefit remains limited. The breakthrough data from the HARMONi-GI1 study strongly support the potential of ivonescimab plus chemotherapy as a new standard of care for first-line treatment of advanced biliary tract cancer. Meanwhile, as the first Phase III study of ivonescimab to achieve positive results in the gastrointestinal tumor field following multiple positive Phase III results in the lung cancer field, this marks that the breakthrough clinical value of ivonescimab is expanding from lung cancer to a broader range of solid tumors. Currently, ivonescimab plus chemotherapy for first-line treatment of biliary tract cancer has been proposed by the National Medical Products Administration for Priority Review status. In addition, ivonescimab's overseas partner Summit Therapeutics has entered into a collaboration with the U.S. ECOG-ACRIN Cancer Research Group and has initiated the global multicenter registrational Phase II/III clinical study EA2251 of ivonescimab plus chemotherapy versus pembrolizumab or durvalumab plus chemotherapy as first-line treatment for advanced biliary tract cancer.