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BNT113 + Keytruda is an investigational combination immunotherapy regimen pairing BioNTech's off-the-shelf mRNA cancer vaccine BNT113 (tenumomeran/raplemomeran) with Merck's anti-PD-1 monoclonal antibody Keytruda (pembrolizumab). BNT113 is an RNA-lipoplex-formulated vaccine encoding the E6 and E7 oncoproteins of human papillomavirus type 16 (HPV16), designed to stimulate a targeted T-cell immune response against HPV16-positive tumor cells. Keytruda blocks the PD-1/PD-L1 pathway, preventing tumor-mediated immune suppression and enhancing the vaccine-induced T-cell response. The combination is being evaluated as a first-line treatment for patients with unresectable recurrent or metastatic HPV16-positive, PD-L1-expressing head and neck squamous cell carcinoma (HNSCC) in the Phase 2/3 AHEAD-MERIT trial (NCT04534205). Although the combination did not meet its dual primary endpoint of progression-free survival (PFS) in October 2026, the trial continues to evaluate overall survival (OS).
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