BioNTech BNT113 fails first clinical endpoint in head and neck cancer trial

BioNTech’s mRNA cancer vaccine candidate, BNT113, has failed to meet its first primary endpoint in the Phase 2/3 AHEAD-MERIT clinical trial. The study evaluated the combination of BNT113 and Pembrolizumab against Pembrolizumab alone for patients with advanced, HPV16-positive head and neck cancer.

The trial failed to demonstrate a statistically significant improvement in progression-free survival (PFS). Despite this setback, the U.S. Food and Drug Administration (FDA) has granted BNT113 Fast Track status for this indication.

An independent data monitoring committee has recommended that the study continue to evaluate the second primary endpoint: overall survival (OS). BioNTech noted that because immune-mediated antitumor effects can build and deepen over time, the analysis of overall survival will be decisive for the treatment's potential efficacy.