Nivolumab, a targeted immunotherapy, significantly prolongs overall survival compared with everolimus among patients with advanced clear-cell renal cell carcinoma (RCC) whose disease progressed after their first treatment, according to study results presented at the 2015 European Cancer Congress in Vienna and published online simultaneously in the New England Journal of Medicine (2015;373:1803-1813).


An immune checkpoint inhibitor monoclonal antibody, nivolumab blocks the interaction between the programmed cell death protein 1 (PD-1) and programmed cell death protein ligand 1 (PD-L1). Interaction between PD-1 and PD-L1 or PD-L2 normally results in inhibition of the cellular immune response. The drug is approved by the FDA for treating metastatic melanoma that no longer responds to other drugs and for treating squamous non-small cell lung cancer.

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In the phase 3 international CheckMate 025 clinical trial, Robert J. Motzer, MD, of Memorial Sloan-Kettering Cancer Center in New York, and colleagues studied 821 patients randomized to receive either nivolumab 3 mg/kg of body weight intravenously every 2 weeks or a 10-mg everolimus table orally once daily. All patients previously had received treatment with 1 or 2 regimens of antiangiogenic therapy. The median overall survival, the study’s primary end point, was 25 months with nivolumab compared with 19.6 months with everolimus. Nivolumab recipients had a significant 27% decreased risk of death compared with everolimus recipients, a difference that the met the prespecified criterion for superiority.


In addition, results showed that nivolumab was associated with a significantly greater objective response rate than everolimus (25% vs. 5%). Median progression-free survival was 4.6 months with nivolumab and 4.4 months with everolimus, a non-significant difference between the treatments.


Grade 3 or 4 treatement-related adverse events (AEs) occurred in 19% of the nivolumab recipients compared with 37% of the everolimus recipients. The most common AE was fatigue in the nivolumab group (2% of patients) and anemia in the everolimus patients (8% of patients).


The trial was discontinued early in July when it became clear that overall survival was superior with nivolumab, with patients offered an opportunity to continue with nivolumab treatment or, for everolimus recipients, to switch to nivolumab.