BioNTech said Tuesday that BNT113, its experimental mRNA cancer immunotherapy, did not extend progression-free survival when combined with Merck’s Keytruda at an interim analysis of a Phase 3 trial in first-line head and neck squamous cell carcinoma driven by the HPV16 strain. A data monitoring committee recommended the trial continue toward its second main objective, overall survival, and BioNTech said the combination showed signs of engaging its intended mechanism. Shares fell about 6 percent in early trading, extending a run of mixed oncology results as the company leans harder on pumitamig, the bispecific antibody it is developing with Bristol Myers Squibb.
BioNTech cancer vaccine misses first endpoint in Phase 3
BioNTech said Tuesday that its mRNA cancer immunotherapy BNT113, combined with Keytruda, failed to delay tumor progression at an interim check in a Phase 3 trial in HPV-driven head and neck cancer, and its shares fell about 6 percent.
Why it matters: The miss is another setback for BioNTech's oncology pivot away from COVID vaccines, leaving the trial's survival endpoint, and the partnered bispecific pumitamig, carrying more of the company's post-pandemic story.
Data as of Tuesday, October 13, 2026, per BioNTech's announcement as reported by BioPharma Dive and Endpoints News, both opened and read. Developing item.
Sources
- BioNTech mRNA cancer immunotherapy misses first objective in key study · BioPharma Dive · 2026-10-13
- BioNTech's head and neck cancer vaccine misses first of two goals · Endpoints News · 2026-10-13