BioNTech SE (BNTX) Form 6-K — Oct 13, 2026
BioNTech announced that BNT113 plus pembrolizumab failed to meet the first dual primary endpoint of progression-free survival in the AHEAD-MERIT Phase 2/3 trial in first-line metastatic HPV16-positive head and neck cancer. The Independent Data Monitoring Committee recommended the trial continue to evaluate the second primary endpoint of overall survival. Under the trial's pre-specified statistical design, a statistically significant OS improvement would still constitute a positive trial outcome despite the PFS miss.
Key figures
- Trial nct
- NCT04534205
- Trial name
- AHEAD-MERIT
- Primary endpoint pfs
- not met
- Fast track designation
- January 2026
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