BioNTech’s investigational mRNA cancer immunotherapy BNT113 failed to significantly improve progression-free survival when added to pembrolizumab in the Phase 2/3 AHEAD-MERIT trial. The study will continue to evaluate overall survival, its other primary endpoint.
The trial is testing the combination against pembrolizumab alone as first-line treatment for patients with unresectable recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma whose tumors express PD-L1.
An independent data monitoring committee recommended continuing the study as planned. Under its prespecified statistical design, a statistically significant overall survival improvement could establish a positive trial outcome despite the progression-free survival miss. BioNTech remains blinded to ongoing trial data.
BNT113, also known as tenumomeran/raplemomeran, encodes the E6 and E7 proteins of HPV16, which are frequently found in HPV16-positive solid tumors. The therapy is designed to stimulate immune responses against those proteins and enhance responses to checkpoint inhibitor treatment.
AHEAD-MERIT includes an initial nonrandomized safety run-in followed by a randomized portion intended to generate pivotal efficacy and safety data. Participants receive the combination or pembrolizumab alone for up to approximately 24 months. Secondary endpoints include safety, objective response rate and duration of response.
Chief Medical Officer Özlem Türeci said the findings supported continued evaluation, while acknowledging that the progression-free survival result was not statistically significant. She said overall survival would be critical to assessing the approach.
BNT113 received FDA Fast Track designation in January 2026. According to BioNTech, approximately one-third of head and neck squamous cell carcinoma cases are associated with HPV infection, and no HPV-targeted treatments are currently approved.
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