Shots:
- BioNTech reported that its P-II/III AHEAD-MERIT study did not meet the first dual 1EP of progression-free survival (PFS) for BNT113 plus pembrolizumab vs pembrolizumab alone in 1L treatment of unresectable recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) expressing PD-L1
- The Independent Data Monitoring Committee recommended continuing the study to evaluate the 2EP of overall survival (OS). Under the prespecified statistical design, a statistically significant OS improvement could potentially establish a positive study outcome despite the unmet PFS endpoint
- Earlier in January 2026, BNT113 received the FTD from the US FDA; BioNTech will continue the OS assessment to evaluate the combination’s potential clinical benefit in pts with HPV16-positive HNSCC
Ref: BioNTech | Image: BioNTech | Press Release
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