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CheckMate 649: Safety profile (ITT)1
No new safety signals were identified with OPDIVO + chemotherapy* at the 3-year analysis.
The table below shows a summary of treatment-related adverse events in the ITT-population. Please note that the EMA indication is limited to patients in the PD-L1 CPS ≥ 5 population.
Treatment-related adverse events of any grade occurred in 95 % of the patients in the OPDIVO + chemotherapy arm and in 89 % of the patients in the chemotherapy arm. No additional deaths occurred with longer follow-up.
Reference:
- Supplementary appendix to Janjigian YY, et al. First-Line Nivolumab Plus Chemotherapy for Advanced Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma: 3-Year Follow-Up of the Phase III CheckMate 649 Trial. J Clin Oncol. 2024 Jun 10;42(17):2012-2020.
7356-NO-2500069 / Developed 11.11.2025