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Yizekang + toripalimab is an investigational combination regimen consisting of izalontamab brengitecan (Yizekang; BL-B01D1), a first-in-class bispecific antibody-drug conjugate (ADC) targeting EGFR and HER3, and toripalimab (Loqtorzi; Tuoyi), a recombinant humanized monoclonal antibody targeting programmed cell death protein 1 (PD-1). Izalontamab brengitecan consists of a bispecific antibody directed against EGFR and HER3, conjugated via a cathepsin-B cleavable linker to Ed-04, a proprietary topoisomerase I inhibitor payload. Toripalimab blocks the interaction of PD-1 with its ligands PD-L1 and PD-L2, thereby restoring T-cell-mediated anti-tumor immune responses. The combination of these two agents is designed to leverage the direct cytotoxic and immunogenic cell death-inducing properties of the bispecific ADC alongside the immune checkpoint inhibition of toripalimab to enhance anti-tumor efficacy. This combination is being evaluated in clinical trials for various advanced solid tumors, including a Phase III trial (PANKU-Breast04) for the first-line treatment of PD-L1-positive, locally recurrent, unresectable, or metastatic triple-negative breast cancer (TNBC).
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