BioNTech’s BNT113 misses PFS in pivotal HPV16+ head-and-neck trial; OS readout continues

BioNTech reported on 13 October 2026 first topline results from the AHEAD-MERIT Phase 2/3 trial (NCT04534205) of investigational mRNA cancer immunotherapy BNT113 (tenumomeran/raplemomeran) plus pembrolizumab versus pembrolizumab alone as first-line treatment for unresectable recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) expressing PD-L1.

Study type and result

This is an open-label, controlled, multi-site, interventional Phase 2/3 study. Part B has dual primary endpoints: progression-free survival (PFS) and overall survival (OS). At the PFS analysis, BNT113 plus pembrolizumab did not show a statistically significant PFS improvement versus pembrolizumab alone. The Independent Data Monitoring Committee recommended continuing as planned to evaluate OS. Under the trial’s pre-specified statistical design, a statistically significant OS benefit would still count as a positive overall outcome even without meeting PFS. BioNTech remains blinded to ongoing data per trial governance.

What BNT113 is and limitations

BNT113 encodes fixed HPV16 E6/E7 antigens and holds FDA Fast Track designation (January 2026) for HPV16+ HNSCC; no HPV-targeted treatments are currently approved for these tumours despite roughly one third of HNSCC being HPV-linked. This update is a company topline release, not a full peer-reviewed dataset: secondary endpoints (safety, ORR, duration of response), magnitude of any OS effect, and subgroup analyses are not yet detailed publicly. Missing PFS does not prove lack of long-term benefit, nor does continued follow-up guarantee an OS win. This is not medical advice; patients should discuss options with their clinicians.