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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; Christian Kollmannsberger; James Larkin; Alain Ravaud; Jason S. Simon; Li-An Xu; Ian M. Waxman; Padmanee Sharma

New England Journal of Medicine, Volume: 373, Issue: 19, Pages: 1803 - 1813

Swansea University Author: Wagstaff, John

DOI (Published version): 10.1056/NEJMoa1510665

Abstract

This randomised phase III trial compared standard of care Everolimus with the anti-PD1 monoclonal antibody Nivolumab in previously treated patients with locally advanced inoperable or metastatic clear cell renal cancer. 810 patients were randomised to receive either Everolimus 10 mg orally daily or...

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Published in: New England Journal of Medicine
Published: 2015
URI: https://cronfa.swan.ac.uk/Record/cronfa25003
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Abstract: This randomised phase III trial compared standard of care Everolimus with the anti-PD1 monoclonal antibody Nivolumab in previously treated patients with locally advanced inoperable or metastatic clear cell renal cancer. 810 patients were randomised to receive either Everolimus 10 mg orally daily or 3 mg/kg of Nivolumab intravenously every two weeks. Patients were treated until unacceptable toxicity or disease progression. Patients could be treated beyond progression if the investigator believed that the patient was gaining clinical benefit. The primary endpoint was overall survival. The median survival was 25 months for Nivolumab and 19.8 months for Everolimus (p=0.002). The objective response rate was higher for Nivolumab (25 versus 5%; p=<0.001).The median progression free survivals were 4.6 & 4.4 months (p=0.11). Grade 3 & 4 treatment related toxicities were observed in 19 & 37% of patients on Nivolumab or Everolimus respectively. In patients with previously treated renal cell carcinoma Nivolumab produced superior survival and more tolerable treatment than Everolimus.
Keywords: Renal Cancer, Nivolumab, Everolimus
College: Swansea University Medical School
Issue: 19
Start Page: 1803
End Page: 1813