EURURO Vol. 72 No. 6

Platinum Priority – Kidney Cancer

Editorial by Sumanta K. Pal, Manuel C. Maia, Nazli Dizman and Neeraj Agarwal on pp. 972–973 of this issue

CheckMate 025 Randomized Phase 3 Study: Outcomes by Key

Baseline Factors and Prior Therapy for Nivolumab Versus

Everolimus in Advanced Renal Cell Carcinoma

Bernard Escudier

a , * ,

Padmanee Sharma

b ,

David F. McDermott

c ,

Saby George

d ,

Hans J. Hammers

e , 1 ,

Sandhya Srinivas

f ,

Scott S. Tykodi

g ,

Jeffrey A. Sosman

h , 2 ,

Giuseppe Procopio

i ,

Elizabeth R. Plimack

j ,

Daniel Castellano

k ,

Howard Gurney

l ,

Frede Donskov

m ,

Katriina Peltola

n ,

John Wagstaff

o ,

Thomas C. Gauler

p ,

Takeshi Ueda

q ,

Huanyu Zhao

r ,

Ian M. Waxman

r ,

Robert J. Motzer

s ,

on behalf of the CheckMate 025 investigators

[1_TD$DIFF]

Gustave Roussy, Villejuif, France;

MD Anderson Cancer Center, University of Texas, Houston, TX, USA;

Beth Israel Deaconess Medical Center, Dana-Farber/

Harvard Cancer Center, Boston, MA, USA;

Roswell Park Cancer Institute, Buffalo, NY, USA;

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center,

Baltimore, MD, USA;

Stanford Cancer Institute, Stanford, CA, USA;

University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA,

USA;

Vanderbilt University Medical Center, Nashville, TN, USA;

Fondazione Istituto Nazionale Tumori, Milan, Italy;

Fox Chase Cancer Center, Philadelphia,

PA, USA;

Hospital Universitario 12 De Octubre, Madrid, Spain;

Westmead Hospital, Westmead, NSW, Australia;

Aarhus University Hospital, Aarhus,

Denmark;

Comprehensive Cancer Center, Helsinki University Central Hospital Cancer Center, Helsinki, Finland;

South West Wales Cancer Institute and

Swansea University College of Medicine, Swansea, UK;

University Hospital Essen of University of Duisburg-Essen, Essen, Germany;

Chiba Cancer Center,

Chiba, Japan;

Bristol-Myers Squibb, Princeton, NJ, USA;

Memorial Sloan Kettering Cancer Center, New York, NY, USA

E U R O P E A N U R O L O G Y 7 2 ( 2 0 1 7 ) 9 6 2 – 9 7 1

available at

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journal homepage:

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Article info

Article history:

Accepted February 7, 2017

Associate Editor:

Giacomo Novara

Keywords:

Everolimus

Immune checkpoint inhibitor

Nivolumab

Phase 3

Renal cell carcinoma

Abstract

Background:

The randomized, phase 3 CheckMate 025 study of nivolumab (

= 410)

versus everolimus (

= 411) in previously treated adults (75% male; 88% white) with

advanced renal cell carcinoma (aRCC) demonstrated significantly improved overall

survival (OS) and objective response rate (ORR).

Objective:

To investigate which baseline factors were associated with OS and ORR

benefit with nivolumab versus everolimus.

Design, setting, and participants:

Subgroup OS analyses were performed using Kaplan-

Meier methodology. Hazard ratios were estimated using the Cox proportional hazards

model.

Intervention:

Nivolumab 3 mg/kg every 2 wk or everolimus 10 mg once daily.

Results and limitations:

The minimum follow-up was 14 mo. Baseline subgroup dis-

tributions were balanced between nivolumab and everolimus arms. Nivolumab dem-

onstrated an OS improvement versus everolimus across subgroups, including Memorial

Sloan Kettering Cancer Center (MSKCC) and International Metastatic Renal Cell Carci-

noma Database Consortium risk groups; age

65 and 65 yr; one and two or more sites

of metastases; bone, liver, and lung metastases; number of prior therapies; duration of

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Current affiliation: UT Southwestern–Kidney Cancer Program, Dallas, TX, USA.

Current affiliation: Robert Lurie Comprehensive Cancer Center of Northwestern University,

Chicago, IL, USA.

* Corresponding author. Gustave Roussy, 114 Rue Edouard Vaillant, 94800 Villejuif, France.

Tel. +33 1 42115410.

E-mail address:

escudier@gustaveroussy.fr

(B. Escudier).

http://dx.doi.org/10.1016/j.eururo.2017.02.010

0302-2838/