BioNTech's mRNA cancer therapy fails to improve progression-free survival in head-neck cancer trial

BioNTech reported that its experimental mRNA cancer immunotherapy, BNT 113, combined with Keytruda, did not meet the primary endpoint of progression-free survival in an interim analysis of a late-stage trial in head-neck squamous cell carcinoma driven by high-risk HPV.

The trial compares the BNT 113-Keytruda combination against Keytruda alone as a first-line treatment. The data monitoring committee’s early check showed no delay in tumor progression for patients receiving the combination.

Despite the missed objective, the committee advised continuation of the study to evaluate the secondary endpoint of overall survival. Company officials said the drug appears to engage its intended mechanism and could still be deemed successful if it later shows a survival benefit.