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Zimlekitug + pembrolizumab (BI-1808 + Keytruda) is an investigational combination immunotherapy regimen being developed for the treatment of advanced malignancies, including cutaneous T-cell lymphoma (CTCL) and platinum-resistant ovarian cancer. Zimlekitug (BI-1808) is a first-in-class, fully human IgG1 monoclonal antibody that targets tumor necrosis factor receptor 2 (TNFR2), which is highly expressed on immunosuppressive regulatory T cells (Tregs) and myeloid cells in the tumor microenvironment. By blocking ligand binding and engaging Fcγ receptors, zimlekitug depletes Tregs and reprograms myeloid cells, thereby promoting CD8+ T-cell expansion and enhancing anti-tumor immunity. Pembrolizumab (Keytruda) is an established anti-PD-1 monoclonal antibody that acts as an immune checkpoint inhibitor. The combination is designed to synergistically overcome tumor-mediated immunosuppression and is being evaluated in the Phase 1/2a KEYNOTE-D20 clinical trial (NCT04752826).
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