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REGN6569 + cemiplimab is a combination of two monoclonal antibodies under clinical investigation for the treatment of advanced solid tumor malignancies. REGN6569 is a fully human IgG1 monoclonal antibody targeting the glucocorticoid-induced tumor necrosis factor receptor–related protein (GITR), an immune modulator expressed on regulatory T cells and activated natural killer cells, functioning primarily as an agonist. Cemiplimab is a monoclonal antibody that binds to programmed cell death-1 (PD-1) and acts as a checkpoint inhibitor. The combination is being studied to enhance anti-tumor immune responses by simultaneously promoting effector immune activity (via GITR agonism) and relieving inhibitory immune regulation (via PD-1 blockade). Both agents are administered intravenously, and the combination has advanced to phase 1/2 clinical trials, including studies in checkpoint inhibitor-naïve and resistant populations across various solid tumors, with expansion cohorts underway in head and neck cancer. Both drugs are developed by Regeneron[1][3][4][6][5].
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