Beating durvalumab plus chemotherapy on overall survival in biliary tract cancer is a meaningful bar to clear: that regimen, which earned FDA accelerated approval in September 2022, pushed median OS to 13 months in the TOPAZ-1 trial and became the established first-line standard. Akeso’s Phase III HARMONi-GI1 trial did exactly that, randomizing 682 patients in China and producing a statistically significant OS benefit for ivonescimab plus chemotherapy against durvalumab plus chemotherapy as the comparator arm.
Those results earned a Presidential Symposium slot at ESMO 2026, the October 23-27 congress in Madrid, where Jian Zhou will deliver them as a Late-Breaking Abstract on October 25. That is the highest-visibility platform ESMO offers, typically reserved for trials whose data are considered practice-changing or sufficiently disruptive to warrant real-time presentation before a packed room of oncologists. Full numbers stay under embargo until the session, so the actual OS difference is not yet public, but the trial design pitted ivonescimab, a PD-1/VEGF bispecific antibody that received its first marketing authorization in China in May 2024, directly against the approved standard rather than against chemotherapy alone.
The biliary dataset is the headline, but Akeso is bringing nearly 30 studies total to Madrid. Ivonescimab features in 12 presentations, including rapid oral readouts on first-line favorable-risk renal cell carcinoma (Phase Ib/II) and recurrent or metastatic thymic carcinoma from the iTHYM study. Cadonilimab, a PD-1/CTLA-4 bispecific, appears in 15 presentations spanning gastric cancer, esophageal squamous cell carcinoma, colorectal cancer, and several rarer tumor types across neoadjuvant and advanced-disease settings.
The immediate number to watch when Zhou takes the podium on October 25 is the median OS difference between arms. If the gap is clinically meaningful beyond the roughly 1.6-month improvement durvalumab showed over chemotherapy alone in TOPAZ-1, it strengthens Akeso’s case for regulatory filings outside China, where the FDA accepted a BLA for ivonescimab in a different indication in January 2026.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
