BioNTech says BNT113 plus pembrolizumab misses progression-free survival endpoint in AHEAD-MERIT trial
BNTX•BioNTech said the BNT113 and pembrolizumab combination missed its progression-free survival endpoint in a Phase 2/3 trial for metastatic HPV16-positive head and neck cancer. Overall survival remains a second dual primary endpoint, with results to be assessed in a future analysis.
1. Trial results
BioNTech disclosed topline results from the AHEAD-MERIT Phase 2/3 trial of BNT113 with pembrolizumab in metastatic HPV16-positive head and neck cancer. The study missed its progression-free survival endpoint.
2. Overall survival pending
The trial is continuing, with overall survival remaining the second dual primary endpoint for a future analysis. Under the pre-specified design, a statistically significant overall survival benefit would still qualify as a positive trial outcome.
