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BioNTech Provides Update on Phase 2/3 Clinical Trial for mRNA Cancer Immunotherapy Candidate ...

The study will continue to overall survival after the combination failed to beat Keytruda alone on progression-free survival, BioNTech said.

  • On Tuesday, BioNTech reported its experimental mRNA cancer immunotherapy BNT113 failed to meet the first main goal of a Phase 3 trial in patients with head and neck cancer, missing the progression-free survival endpoint.
  • The trial tested BNT113 combined with Keytruda against Keytruda alone as a first-line treatment for advanced HNSCC patients with the HPV16 virus.
  • Chief Medical Officer Özlem Türeci said early results "support continued evaluation" and show the drug is "engaging its intended therapeutic mechanism," despite missing the primary endpoint.
  • US-Listed shares of BioNTech fell nearly 6% on Tuesday following the announcement, though an independent data monitoring committee recommended the study continue to evaluate overall survival.
  • Leerink Partners analyst Daina Graybosch noted evidence supporting BNT113 activity was "sparse" when the Phase 3 study launched, as BioNTech pivots resources from infectious disease back to oncology.
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BioNTech's mRNA cancer therapy misses first goal in head and neck trial

·London, United Kingdom
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Hastings Tribune broke the news in Nebraska, United States on Tuesday, October 13, 2026.
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