BioNTech Provides Update on Phase 2/3 Clinical Trial for mRNA Cancer Immunotherapy Candidate BNT113 in Metastatic HPV16-positive Head and Neck Cancer
BioNTech's AHEAD-MERIT Phase 2/3 trial of BNT113 plus pembrolizumab missed its first dual primary endpoint of progression-free survival versus pembrolizumab alone in first-line metastatic HPV16+ head and neck cancer. The IDMC recommended the trial continue to the second dual primary endpoint of overall survival; under the pre-specified design, a statistically significant OS improvement would still constitute a positive trial outcome despite the PFS miss.
Key figures
- Drug Name
- BNT113 (tenumomeran/raplemomeran)
- Phase Of Trial
- Phase 2/3
- Indication
- first-line unresectable recurrent/metastatic HPV16+ head and neck squamous cell carcinoma
- Trial name
- AHEAD-MERIT
- Combination
- BNT113 plus pembrolizumab vs pembrolizumab monotherapy
- Os endpoint
- ongoing
- Pfs endpoint
- not met
AI analysis
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