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A new treatment combo is shaking up biliary tract cancer care. The phase 3 HARMONi-GI1 trial found that ivonescimab plus chemotherapy significantly extended overall survival compared to durvalumab plus chemotherapy in previously untreated advanced biliary tract cancer. Researchers are calling it a new standard of care for this hard-to-treat cancer.
A new treatment combination is rewriting the playbook for advanced biliary tract cancer (BTC). Results from the phase 3 HARMONi-GI1 trial, presented at the 2026 ESMO Congress, showed that ivonescimab plus chemotherapy significantly improved overall survival (OS) compared to durvalumab plus chemotherapy in patients with previously untreated advanced BTC — making it the first phase 3 trial in this cancer type to demonstrate such a meaningful OS benefit over durvalumab-based therapy.
The trial enrolled 682 patients who were randomized to receive either ivonescimab or durvalumab alongside gemcitabine and cisplatin. Benefits were seen across all key endpoints, including OS, progression-free survival, and objective response rate, with improvements observed across tumor subtypes including intrahepatic cholangiocarcinoma and gallbladder cancer.
By the Numbers:
Why it matters: Biliary tract cancers are aggressive and often diagnosed at advanced stages, leaving patients with limited options. This trial establishes ivonescimab plus chemotherapy as a new first-line standard of care, offering a meaningful survival advantage — a significant step forward for a disease with historically poor outcomes.