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BNT113 + pembrolizumab is an investigational combination therapy under clinical evaluation for the treatment of unresectable recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) expressing PD-L1. **BNT113** is an mRNA-based therapeutic cancer vaccine developed by BioNTech, designed to induce immune responses specifically against HPV16-positive cancers. **Pembrolizumab** is a checkpoint inhibitor (monoclonal antibody) developed by Merck that blocks the programmed cell death protein 1 (PD-1) pathway, enhancing the immune response against tumor cells. The combination is hypothesized to provide synergistic anti-tumor activity by priming and enhancing immune recognition (BNT113) while preventing T-cell inhibition via PD-1 blockade (pembrolizumab). This combination is being studied in a Phase II/III clinical trial as first-line treatment for eligible HNSCC patients[1][2][3][4][5].
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