BioNTech's Head and Neck Cancer Therapy Misses Progression-free Survival Endpoint

07:41 AM EDT, 10/13/2026 (MT Newswires) -- BioNTech's (22UA.F) mRNA cancer immunotherapy candidate BNT113 failed to show a statistically significant improvement in progression-free survival in the Ahead-Merit phase 2/3 clinical trial, according to a Tuesday release. The Germany-listed pharmaceutical group is assessing the drug candidate in combination with pembrolizumab against pembrolizumab monotherapy as a first-line treatment for patients with unresectable recurrent or metastatic human papillomavirus 16-positive head and neck squamous cell carcinoma expressing PD-L1. The trial will continue to evaluate the second dual primary endpoint of overall survival as recommended by the Independent Data Monitoring Committee. Under the trial's predefined statistical design, a statistically significant improvement in overall survival would establish a positive trial outcome even though the progression-free survival endpoint was not met, the company said.