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This combination therapy consists of toripalimab, a humanized IgG4 monoclonal antibody targeting the programmed cell death protein 1 (PD-1) receptor, and Bacillus Calmette-Guérin (BCG), a live-attenuated strain of Mycobacterium bovis. Toripalimab, developed by Shanghai Junshi Biosciences, acts as an immune checkpoint inhibitor by blocking the interaction between PD-1 and its ligands (PD-L1 and PD-L2), thereby enhancing T-cell mediated anti-tumor immunity. BCG is the standard-of-care intravesical immunotherapy for non-muscle-invasive bladder cancer (NMIBC), working by inducing a robust local innate and adaptive immune response within the bladder wall. This specific regimen, being evaluated in a Phase 2 trial at Changhai Hospital, involves intravenous toripalimab and intravesical BCG instillation as adjuvant therapy following transurethral resection of bladder tumor (TURBT) in patients with high-risk or very high-risk NMIBC. The goal of the combination is to leverage synergistic immune activation to improve pathological complete response rates and prevent disease recurrence or progression.
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