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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.