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Stapokibart + tislelizumab is an investigational combination immunotherapy regimen being evaluated for the treatment of advanced malignancies, specifically non-small cell lung cancer (NSCLC). Stapokibart (CM310) is a humanized monoclonal antibody that targets the interleukin-4 receptor alpha (IL-4Rα) subunit, thereby blocking the signaling of IL-4 and IL-13. This action is intended to modulate the tumor microenvironment by reducing the presence of immunosuppressive Type 2 immune cells, such as M2-type macrophages. Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody engineered to minimize binding to FcγR on macrophages, which is hypothesized to enhance its anti-tumor activity by preventing antibody-dependent cellular phagocytosis (ADCP). The combination is currently being studied in a Phase 2 clinical trial sponsored by Sichuan University for patients with driver gene-negative NSCLC who have previously failed PD-1/PD-L1 inhibitor therapy, aiming to overcome resistance to checkpoint inhibition.
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