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Bulumtatug fuvedotin plus toripalimab is an investigational combination therapy consisting of bulumtatug fuvedotin (BFv; 9MW2821), a Nectin-4-directed antibody-drug conjugate (ADC), and toripalimab, a recombinant humanized anti-PD-1 monoclonal antibody. Bulumtatug fuvedotin is developed by Mabwell and utilizes a site-specific interchain-disulfide conjugation technology to link a humanized anti-Nectin-4 antibody to the microtubule inhibitor monomethyl auristatin E (MMAE) via a cleavable valine-citrulline linker. Toripalimab, developed by Junshi Biosciences, is an immune checkpoint inhibitor that blocks the interaction between PD-1 and its ligands. The combination is being evaluated in Phase Ib/II and Phase III clinical trials for the treatment of locally advanced or metastatic urothelial carcinoma, recurrent or metastatic cervical cancer, and perioperative muscle-invasive bladder cancer (MIBC). Early clinical data have demonstrated encouraging antitumor activity and a manageable safety profile.
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