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On September 14, 2026, BioNTech SE and OncoC4 announced updated median overall survival data from the non-pivotal…

BNTXBioNTech SE

On September 14, 2026, BioNTech SE and OncoC4 announced updated median overall survival data from the non-pivotal stage 1 of the PRESERVE-003 Phase 3 clinical trial for gotistobart (BNT316/ONC-392) in patients with squamous non-small cell lung cancer. The investigational immunotherapy demonstrated a median overall survival of 18.5 months compared to 10.0 months for standard-of-care docetaxel chemotherapy, representing nearly double the survival benefit (HR: 0.56; nominal p-value=0.0295). This data was presented at the IASLC 2026 World Conference on Lung Cancer and supports gotistobart's potential as a chemotherapy-free monotherapy. BioNTech SE is a global biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases.

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