BioNTech and OncoC4 reported a late‑stage win for their anti‑CTLA‑4 antibody, with the Phase 3 trial showing a greater than 50% reduction in risk of death. The lead dataset marks a major efficacy readout after the program previously faced a partial FDA hold. At the same time, a follow‑up analysis flagged a challenging safety and tolerability profile, with higher rates of immune‑related adverse events than typical for frontline regimens. Company releases and a sponsor analysis provided the efficacy figures and the safety breakdowns. Regulators will weigh the survival benefit against the safety concerns in any review; the juxtaposition of strong overall survival data and notable toxicity will shape labeling, post‑market safety commitments, and the commercial path if cleared.