Nivolumab versus everolimus in advanced renal-cell carcinoma

Robert J. Motzer, Bernard Escudier, David F. McDermott, Saby George, Hans J. Hammers, Sandhya Srinivas, Scott S. Tykodi, Jeffrey A. Sosman, Giuseppe Procopio, Elizabeth R. Plimack, Daniel Castellano, Toni K. Choueiri, Howard Gurney, Frede Donskov, Petri Bono, John Wagstaff, Thomas C. Gauler, Takeshi Ueda, Yoshihiko Tomita, Fabio A. Schutz & 7 others Christian Kollmannsberger, James Larkin, Alain Ravaud, Jason S. Simon, Li An Xu, Ian M. Waxman, Padmanee Sharma

Research output: Contribution to journalArticle

Abstract

BACKGROUND 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. METHODS 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. RESULTS 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

Original languageEnglish (US)
Pages (from-to)1803-1813
Number of pages11
JournalNew England Journal of Medicine
Volume373
Issue number19
DOIs
StatePublished - Nov 5 2015
Externally publishedYes

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Renal Cell Carcinoma
Confidence Intervals
Survival
Tablets
Everolimus
nivolumab
Therapeutics
Odds Ratio
Body Weight
Safety

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Motzer, R. J., Escudier, B., McDermott, D. F., George, S., Hammers, H. J., Srinivas, S., ... Sharma, P. (2015). Nivolumab versus everolimus in advanced renal-cell carcinoma. New England Journal of Medicine, 373(19), 1803-1813. https://doi.org/10.1056/NEJMoa1510665

Nivolumab versus everolimus in advanced renal-cell carcinoma. / 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.

In: New England Journal of Medicine, Vol. 373, No. 19, 05.11.2015, p. 1803-1813.

Research output: Contribution to journalArticle

Motzer, RJ, Escudier, B, McDermott, DF, George, S, Hammers, HJ, Srinivas, S, Tykodi, SS, Sosman, JA, Procopio, G, Plimack, ER, Castellano, D, Choueiri, TK, Gurney, H, Donskov, F, Bono, P, Wagstaff, J, Gauler, TC, Ueda, T, Tomita, Y, Schutz, FA, Kollmannsberger, C, Larkin, J, Ravaud, A, Simon, JS, Xu, LA, Waxman, IM & Sharma, P 2015, 'Nivolumab versus everolimus in advanced renal-cell carcinoma', New England Journal of Medicine, vol. 373, no. 19, pp. 1803-1813. https://doi.org/10.1056/NEJMoa1510665
Motzer RJ, Escudier B, McDermott DF, George S, Hammers HJ, Srinivas S et al. Nivolumab versus everolimus in advanced renal-cell carcinoma. New England Journal of Medicine. 2015 Nov 5;373(19):1803-1813. https://doi.org/10.1056/NEJMoa1510665
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. / Nivolumab versus everolimus in advanced renal-cell carcinoma. In: New England Journal of Medicine. 2015 ; Vol. 373, No. 19. pp. 1803-1813.
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T1 - Nivolumab versus everolimus in advanced renal-cell carcinoma

AU - Motzer, Robert J.

AU - Escudier, Bernard

AU - McDermott, David F.

AU - George, Saby

AU - Hammers, Hans J.

AU - Srinivas, Sandhya

AU - Tykodi, Scott S.

AU - Sosman, Jeffrey A.

AU - Procopio, Giuseppe

AU - Plimack, Elizabeth R.

AU - Castellano, Daniel

AU - Choueiri, Toni K.

AU - Gurney, Howard

AU - Donskov, Frede

AU - Bono, Petri

AU - Wagstaff, John

AU - Gauler, Thomas C.

AU - Ueda, Takeshi

AU - Tomita, Yoshihiko

AU - Schutz, Fabio A.

AU - Kollmannsberger, Christian

AU - Larkin, James

AU - Ravaud, Alain

AU - Simon, Jason S.

AU - Xu, Li An

AU - Waxman, Ian M.

AU - Sharma, Padmanee

PY - 2015/11/5

Y1 - 2015/11/5

N2 - BACKGROUND 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. METHODS 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. RESULTS 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

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