AKESO (09926) has announced that the HARMONi-GI1/AK112鈥?09 study 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鈥?09 (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 participants. In August 2026, a pre-specified interim analysis assessed by the Independent Data Monitoring Committee (IDMC) showed that the study met its primary endpoint of overall survival (OS), achieving a statistically significant and clinically meaningful positive result; the study also met all key secondary endpoints including progression-free survival (PFS) and objective response rate (ORR).
Trial results showed that in the ITT population, the ivonescimab group had a median OS (mOS) of 14.9 months versus 12.1 months for the durvalumab group, with an OS HR of 0.75 (95% CI: 0.61鈥?.92), representing a 25% reduction in the risk of death (P=0.0031). The 12-month OS rates for the ivonescimab group versus the durvalumab group were 59.7% vs 50.7%, and the 18-month OS rates were 44.0% vs 32.5%. The ivonescimab group had a median PFS (mPFS) of 8.4 months versus 5.8 months for the durvalumab group, with a PFS HR of 0.61 (95% CI: 0.51鈥?.72), representing a 39% reduction in the risk of disease progression or death (P<0.0001). The ORR for the ivonescimab group versus the durvalumab group was 53.8% vs 32.5%, with an absolute difference (螖) of 21.3% (P<0.0001). The ivonescimab group demonstrated a favorable overall safety profile with longer duration of study drug 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 malignancy is a highly heterogeneous malignancy 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 yield positive results in the gastrointestinal tumor field following multiple positive Phase III results in the lung cancer field, this marks the expansion of ivonescimab's breakthrough clinical value 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 EA2251 study evaluating ivonescimab plus chemotherapy versus pembrolizumab or durvalumab plus chemotherapy as first-line treatment for advanced biliary tract cancer.
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