BNT113 and KEYTRUDA (pembrolizumab) - (AHEAD-MERIT)

October 13, 2026: BioNTech SE (NASDAQ: BNTX) reported first topline results from the AHEAD-MERIT Phase 2/3 trial (NCT04534205) of BNT113 (tenumomeran/raplemomeran) plus pembrolizumab versus pembrolizumab alone in first-line unresectable recurrent or metastatic HPV16-positive, PD-L1-positive head and neck squamous cell carcinoma.

The Phase 3 portion did not meet the first dual primary endpoint: progression-free survival was not statistically significantly improved versus pembrolizumab monotherapy. The Independent Data Monitoring Committee recommended the trial continue as planned to evaluate the second dual primary endpoint, overall survival. Under the pre-specified statistical design, a statistically significant overall survival benefit would still constitute a positive trial outcome even though the PFS endpoint was missed.

AHEAD-MERIT is an open-label, 2-arm Phase 2/3 study; secondary endpoints include safety, objective response rate, and duration of response. BioNTech said it remains blinded to ongoing trial data.

BNT113 is an investigational mRNA cancer immunotherapy targeting HPV16 E6 and E7 antigens. The release also notes BNT113 received FDA Fast Track Designation in January 2026.