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Iparomlimab + Tuvonralimab is an immunotherapy combination regimen currently being evaluated for the treatment of advanced biliary tract cancer. The regimen consists of iparomlimab (AK105, penpulimab), a humanized IgG1 monoclonal antibody targeting the programmed cell death protein 1 (PD-1) receptor, and tuvonralimab (AK104, cadonilimab), a first-in-class bispecific antibody that simultaneously targets both PD-1 and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). By blocking these two distinct immune checkpoints, the combination aims to synergistically enhance anti-tumor T-cell activation and overcome immune evasion mechanisms within the tumor microenvironment. This regimen is being investigated in the SAIB (Sequential Anti-angiogenic Therapy in Biliary Tract Cancer) trial, a randomized Phase 2 study sponsored by the First Affiliated Hospital of Zhejiang University, where it is administered as a first-line therapy in combination with gemcitabine and cisplatin chemotherapy.
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