Germany-based BioNTech (Nasdaq: BNTX) reported that its mRNA cancer immunotherapy BNT113 (tenumomeran/raplemomeran) plus pembrolizumab did not demonstrate a statistically significant improvement in progression-free survival (PFS) versus pembrolizumab alone in the Phase III portion of the AHEAD-MERIT trial in first-line HPV16-positive head and neck squamous cell carcinoma (HNSCC). The trial's Independent Data Monitoring Committee recommended continuing the study to evaluate overall survival (OS), its second primary endpoint, with the prespecified statistical design allowing a statistically significant OS result to establish a positive trial outcome.
BNT113 is an off-the-shelf mRNA immunotherapy encoding the HPV16 E6 and E7 oncoproteins, which are expressed in HPV16-associated tumors. It is designed to induce HPV16-specific antitumor immune responses and enhance the activity of pembrolizumab, a PD-1 checkpoint inhibitor. The candidate received US FDA Fast Track designation in January 2026.
Pembrolizumab (Keytruda), developed by Merck, is approved for first-line treatment of recurrent or metastatic HNSCC. BioNTech said no HPV-targeted treatment is currently approved for the disease. In September 2026, San Diego-based Inhibrx Biosciences (Nasdaq: INBX) reported a confirmed response rate of 48.3% with its OX40 agonist INBRX-106 plus pembrolizumab versus 26.5% with pembrolizumab alone in a randomized Phase II HNSCC study, including rates of 80.0% versus 33.3% in a small HPV-positive subgroup.
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