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Fisogatinib + sugemalimab is an investigational combination therapy for cancer, primarily studied in hepatocellular carcinoma (HCC) with FGF19 expression. Fisogatinib (BLU-554) is a highly potent and selective oral small molecule inhibitor of fibroblast growth factor receptor 4 (FGFR4), developed to target cancers driven by aberrant FGF19/FGFR4 signaling. Sugemalimab (CS1001, brand name Cejemly) is a fully human, full-length IgG4 monoclonal antibody that targets programmed death ligand 1 (PD-L1), blocking its interaction with PD-1 and CD80 to enhance antitumor immune responses. The combination aims to inhibit tumor proliferation via FGFR4 blockade while simultaneously enhancing immune-mediated tumor cell killing through PD-L1 inhibition. Both agents have demonstrated manageable safety profiles and preliminary antitumor activity in early-phase clinical trials for advanced HCC and other solid tumors[3][7][8].
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