Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma.

Abstract (PubMed)

Nivolumab, a programmed death 1 (PD-1) checkpoint inhibitor, was associated with encouraging overall survival in uncontrolled studies in previously treated patients with advanced renal-cell carcinoma. This randomized, open-label, phase 3 study (CheckMate 025) compared nivolumab with everolimus in patients with advanced renal-cell carcinoma who had received prior antiangiogenic therapy. A total of 821 patients were randomized 1:1 to receive nivolumab (3 mg/kg intravenously every 2 weeks) or everolimus (10 mg orally per day). The primary end point was overall survival. Median overall survival was 25.0 months with nivolumab versus 19.6 months with everolimus (hazard ratio 0.73; 98.5% CI 0.57–0.93; P=0.002). The objective response rate was 25% with nivolumab versus 5% with everolimus. Grade 3 or 4 treatment-related adverse events occurred in 19% of patients receiving nivolumab and 37% of those receiving everolimus. Nivolumab significantly improved overall survival and was associated with fewer grade 3–4 adverse events than everolimus.