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Title:

Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma.

Document type:
journal article
Author(s):
Motzer, Robert J; Escudier, Bernard; McDermott, David F; George, Saby; Hammers, Hans J; Srinivas, Sandhya; Tykodi, Scott S; Sosman, Jeffrey A; Procopio, Giuseppe; Plimack, Elizabeth R; Castellano, Daniel; Choueiri, Toni K; Gurney, Howard; Donskov, Frede; Bono, Petri; Wagstaff, John; Gauler, Thomas C; Ueda, Takeshi; Tomita, Yoshihiko; Schutz, Fabio A; Kollmannsberger, Christian; Larkin, James; Ravaud, Alain; Simon, Jason S; Xu, Li-An; Waxman, Ian M; Sharma, Padmanee; CheckMate 025 Investigators;...     »
Abstract:
Nivolumab, a programmed death 1 (PD-1) checkpoint inhibitor, was associated with encouraging overall survival in uncontrolled studies involving previously treated patients with advanced renal-cell carcinoma. This randomized, open-label, phase 3 study compared nivolumab with everolimus in patients with renal-cell carcinoma who had received previous treatment.A total of 821 patients with advanced clear-cell renal-cell carcinoma for which they had received previous treatment with one or two regimens of antiangiogenic therapy were randomly assigned (in a 1:1 ratio) to receive 3 mg of nivolumab per kilogram of body weight intravenously every 2 weeks or a 10-mg everolimus tablet orally once daily. The primary end point was overall survival. The secondary end points included the objective response rate and safety.The median overall survival was 25.0 months (95% confidence interval [CI], 21.8 to not estimable) with nivolumab and 19.6 months (95% CI, 17.6 to 23.1) with everolimus. The hazard ratio for death with nivolumab versus everolimus was 0.73 (98.5% CI, 0.57 to 0.93; P=0.002), which met the prespecified criterion for superiority (P<=0.0148). The objective response rate was greater with nivolumab than with everolimus (25% vs. 5%; odds ratio, 5.98 [95% CI, 3.68 to 9.72]; P<0.001). The median progression-free survival was 4.6 months (95% CI, 3.7 to 5.4) with nivolumab and 4.4 months (95% CI, 3.7 to 5.5) with everolimus (hazard ratio, 0.88; 95% CI, 0.75 to 1.03; P=0.11). Grade 3 or 4 treatment-related adverse events occurred in 19% of the patients receiving nivolumab and in 37% of the patients receiving everolimus; the most common event with nivolumab was fatigue (in 2% of the patients), and the most common event with everolimus was anemia (in 8%).Among patients with previously treated advanced renal-cell carcinoma, overall survival was longer and fewer grade 3 or 4 adverse events occurred with nivolumab than with everolimus. (Funded by Bristol-Myers Squibb; CheckMate 025 ClinicalTrials.gov number, NCT01668784.).
Journal title abbreviation:
N Engl J Med
Year:
2015
Journal volume:
373
Journal issue:
19
Pages contribution:
1803-13
Language:
eng
Pubmed ID:
http://view.ncbi.nlm.nih.gov/pubmed/26406148
Print-ISSN:
0028-4793
TUM Institution:
Urologische Klinik und Poliklinik
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