BNT113 misses AHEAD-MERIT progression-free survival endpoint; overall survival follow-up continues
Published in Diseases!, Drugs development & discovery, Immunology.
Publication date: October 13, 2026.
BioNTech reported that BNT113 plus pembrolizumab did not significantly improve progression-free survival compared with pembrolizumab alone in AHEAD-MERIT. This phase II/III trial evaluates first-line treatment for unresectable recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma expressing PD-L1.
The randomized part has two primary endpoints: progression-free survival and overall survival. The independent monitoring committee recommended continuing the trial to assess overall survival. Under the prespecified statistical design, a significant overall-survival benefit could still establish a positive trial outcome despite the progression-free-survival result.
BNT113 is an investigational mRNA immunotherapy encoding HPV16 E6 and E7 proteins, intended to stimulate tumor-directed immune responses. BioNTech says it remains blinded to ongoing trial data.
Limits: the company has not disclosed numerical hazard ratios, confidence intervals or detailed safety results in this update. Continued follow-up does not demonstrate that a survival benefit will emerge. BNT113 remains investigational; these findings should not be generalized to all mRNA cancer therapies.
Source: BioNTech announcement, October 13, 2026. Trial: NCT04534205.