BioNTech announced on October 13, 2026, that its experimental mRNA therapy BNT113 failed to meet its progression-free survival endpoint in a Phase 2/3 trial for HPV16-positive head and neck cancer when combined with Merck's Keytruda. Following the news, BioNTech's shares fell nearly 3%. The trial will continue to evaluate overall survival, which analysts note could still establish a positive trial outcome.
BNT113 progression-free survival failure
- ▪BioNTech announced on October 13, 2026, that its experimental mRNA cancer immunotherapy BNT113 failed to meet its primary endpoint of progression-free survival in a Phase 2/3 trial
- ▪Following the BNT113 trial announcement on October 13, 2026, BioNTech's US-listed shares declined by nearly 3% during early trading
HPV16-positive head neck carcinoma
- ▪The Phase 2/3 clinical trial evaluated BioNTech's BNT113 combination therapy in patients with advanced human papillomavirus 16-positive head and neck squamous cell carcinoma
- ▪The Phase 2/3 trial tested BioNTech's BNT113 combined with Merck's pembrolizumab against pembrolizumab monotherapy in advanced head and neck cancer patients
BioNTech share price decline
- ▪Following the BNT113 trial announcement on October 13, 2026, BioNTech's US-listed shares declined by nearly 3% during early trading
- ▪BioNTech announced on October 13, 2026, that its experimental mRNA cancer immunotherapy BNT113 failed to meet its primary endpoint of progression-free survival in a Phase 2/3 trial
Pembrolizumab combination therapy trial
- ▪The Phase 2/3 trial tested BioNTech's BNT113 combined with Merck's pembrolizumab against pembrolizumab monotherapy in advanced head and neck cancer patients
- ▪The Phase 2/3 clinical trial evaluated BioNTech's BNT113 combination therapy in patients with advanced human papillomavirus 16-positive head and neck squamous cell carcinoma
Overall survival endpoint continuation
- ▪An independent data monitoring committee recommended that BioNTech continue the BNT113 trial to evaluate its secondary primary endpoint of overall survival
- ▪Previous cancer immunotherapies have secured regulatory approvals after failing progression-free survival endpoints if they demonstrated statistically significant overall survival benefits
Analyst commentary on immunosuppression
- ▪Citi analyst Geoffrey Meacham noted that head and neck squamous cell carcinoma is heavily immunosuppressed and heterogeneous, complicating efforts to show incremental efficacy over pembrolizumab
- ▪Citi analyst Geoffrey Meacham stated that achieving a statistically significant overall survival benefit would establish a successful outcome for BioNTech's BNT113 trial despite the BNT113 trial's progression-free survival miss
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