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BioNTech's BNT113 misses PFS endpoint in AHEAD-MERIT trial but OS analysis continues
BNTXBioNTech SE
BioNTech announced first topline results from the Phase 2/3 AHEAD-MERIT clinical trial for its investigational mRNA cancer immunotherapy candidate BNT113. The trial did not meet its first dual primary endpoint of progression-free survival (PFS) when comparing BNT113 plus pembrolizumab against pembrolizumab alone in patients with metastatic HPV16-positive head and neck squamous cell carcinoma. However, the Independent Data Monitoring Committee recommended continuing the trial to evaluate the second dual primary endpoint of overall survival (OS). Under the pre-specified statistical design, a statistically significant improvement in OS would establish a positive outcome despite the PFS result. BioNTech is a global biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases.