BioNTech (Nasdaq: BNTX) and OncoC4 reported that selective Treg modulator gotistobart (BNT316/ONC-392) showed a clinically meaningful overall survival benefit versus docetaxel in the non-pivotal stage of the global Phase 3 PRESERVE-003 trial in previously treated metastatic squamous NSCLC.
At a 14.5-month median follow-up, median OS with gotistobart was not reached versus 10 months with docetaxel; 12-month OS was 63.1% vs 30.3%. Hazard ratio for death was 0.46 (95% CI 0.25–0.84) with nominal p=0.0102. Safety remained manageable; grade ≥3 TRAEs were 42.2% vs 48.8%.
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