Comparative real-world safety of nivolumab versus pembrolizumab in malignant melanoma: A propensity-matched cohort study
Abstract
e21587
Background:
Nivolumab and pembrolizumab are widely used programmed cell death-1 (PD-1) inhibitors approved for the treatment of malignant melanoma. Although both agents demonstrate comparable efficacy, real-world comparative safety data between these two therapies remain limited. We conducted a real-world cohort study to compare immune-related adverse events between nivolumab and pembrolizumab in patients with melanoma.
Methods:
We performed a retrospective cohort study using the TriNetX Global Collaborative Network, including adult patients (≥18 years) diagnosed with malignant melanoma treated with either nivolumab or pembrolizumab between January 2015 and December 2025. Patients receiving other immune checkpoint inhibitors were excluded. Propensity score matching (1:1) was used to balance baseline demographics and comorbidities, yielding 6,028 patients in each cohort. Outcomes assessed within three years after treatment initiation included pneumonia, inflammatory liver disease, autoimmune thyroiditis, type 1 diabetes mellitus, colitis, myocarditis, and dermatitis/eczema. Risk ratios, hazard ratios, Kaplan–Meier survival analyses, and number of event instances were evaluated.
Results:
After matching, baseline demographic and clinical characteristics were well balanced between the two cohorts. Nivolumab was associated with a significantly lower risk of pneumonia compared with pembrolizumab (risk ratio [RR] 0.89, 95% CI 0.81–0.99; hazard ratio [HR] 0.89, 95% CI…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 6,028 participants or records.
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