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Ivonescimab + gemcitabine + cisplatin is an investigational combination regimen consisting of ivonescimab, a first-in-class PD-1/VEGF bispecific monoclonal antibody, co-administered with the standard chemotherapy doublet gemcitabine (a nucleoside analog) and cisplatin (a platinum-containing alkylating agent). This combination is primarily developed as a first-line treatment for patients with unresectable locally advanced or metastatic biliary tract cancer (BTC). Ivonescimab simultaneously blocks the PD-1/PD-L1 immune checkpoint pathway and VEGF-A-mediated angiogenesis, while gemcitabine and cisplatin provide synergistic cytotoxic tumor cell destruction by inhibiting DNA synthesis and inducing DNA damage. In the Phase III HARMONi-GI1 trial, this regimen demonstrated a statistically significant and clinically meaningful overall survival benefit compared to the standard-of-care durvalumab plus gemcitabine and cisplatin.
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