hazard ratio
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BioNTech and OncoC4 Report Significant Overall Survival Benefit of Gotistobart in Previously Treated Squamous NSCLC Patients
BioNTech and OncoC4 presented non‑pivotal Phase 3 PRESERVE‑003 data for the selective T‑reg modulator gotistobart (BNT316/ONC‑392) in previously treated metastatic squamous NSCLC. With 45 patients on gotistobart and 42 on docetaxel, median overall survival was not reached versus 10 months, and 12‑month OS rates were 63.1 % versus 30.3 %. The hazard ratio for death was 0.46 (95 % CI 0.25–0.84; p = 0.0102). Grade ≥ 3 treatment‑related adverse events occurred in 42.2 % of gotistobart patients. The drug holds FDA Fast Track status.
