A deeper read of phase 3 data for BioNTech and OncoC4’s anti‑CTLA‑4 antibody confirmed a survival benefit but highlighted a challenging safety profile. Analysts and clinicians flagged tolerability concerns that could complicate regulatory review and clinical adoption despite the efficacy signal. The balance of improved overall survival against higher rates of immune‑related adverse events will dictate label language, required risk‑mitigation strategies, and where the antibody fits in treatment algorithms for solid tumors. BioNTech will likely need to present supportive safety management data to payers and regulators.
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