Safety Profile of Nivolumab-Relatlimab in Cancer Patients: A Living Pharmacovigilance Study

Strategic Insights -

A new study on the safety profile of nivolumab-relatlimab in cancer patients has been published in the European Journal of Pharmacology. The research integrated data from clinical trials and the FDA Adverse Event Reporting System (FAERS) database to assess the safety profile of the treatment. The study found that the incidence of all-grade and high-grade treatment-related adverse events (TRAEs) for nivolumab-relatlimab was 74.11% and 38.05%, respectively.

Key Takeaways:

  • The study included 12 trials and found that nivolumab-relatlimab was associated with a significantly increased risk of high-grade TRAEs compared to nivolumab monotherapy.
  • The incidence of individual specified all-grade TRAEs, including hypothyroidism/thyroiditis, rash, diarrhea/colitis, hepatitis, adrenal insufficiency, hypophysitis, arthralgia, and myalgia, was higher with nivolumab-relatlimab than with nivolumab monotherapy.
  • Disproportionality analyses of FAERS pharmacovigilance data identified 39 positive signals, with 18 AEs not mentioned in the drug label, including 15 AEs with significantly higher reporting frequencies for nivolumab-relatlimab compared to nivolumab monotherapy.
  • The study provides valuable insights into the potential safety profile of nivolumab-relatlimab, and the results will be updated to incorporate new evidence as it becomes available.

Statistics:

  • Incidence of all-grade TRAEs for nivolumab-relatlimab: 74.11%
  • Incidence of high-grade TRAEs for nivolumab-relatlimab: 38.05%
  • Reporting frequencies for 15 AEs were significantly higher for nivolumab-relatlimab compared to nivolumab monotherapy
  • Number of positive signals identified in FAERS pharmacovigilance data: 39
  • Number of AEs not mentioned in the drug label: 18

Sources:

  • NewsRx. Findings from Jinan University Broadens Understanding of Cancer [Safety profile of nivolumab-relatlimab in cancer patients: a living pharmacovigilance study of clinical trials and postmarketing data (version 1.0)]. Immunotherapy Weekly. August 13, 2025; p 975.
  • European Journal of Pharmacology, "Safety profile of nivolumab-relatlimab in cancer patients: a living pharmacovigilance study of clinical trials and postmarketing data (version 1.0)", 2025:177991.
  • European Journal of Pharmacology, "Elsevier, Radarweg 29, 1043 Nx Amsterdam, Netherlands."
  • Jinan University, College of Pharmacy, Guangzhou, People's Republic of China.