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Author contributions: Bernard Escudier had full access to all the data in
the study and takes responsibility for the integrity of the data and the
accuracy of the data analysis.
Study concept and design: Zhao, Hardy.
Acquisition of data: Escudier, Motzer, Sharma, Wagstaff, Plimack,
Hammers, Donskov, Gurney, Sosman, Zalewski, Harmenberg, McDer-
mott, Choueiri, Richardet, Tomita, Ravaud, George.
Analysis and interpretation of data: All authors.
Drafting of the manuscript: Escudier, George.
Critical revision of the manuscript for important intellectual content: All
authors.
Statistical analysis: Zhao.
Obtaining funding: None.
Administrative, technical, or material support: Doan.
Supervision: None.
Other: None.
Financial disclosures: Bernard Escudier certifies that all conflicts of
interest, including specific financial interests and relationships and
affiliations relevant to the subject matter or materials discussed in the
manuscript (eg, employment/affiliation, grants or funding, consultan-
cies, honoraria, stock ownership or options, expert testimony, royalties,
or patents filed, received, or pending), are the following: Escudier has
received honoraria from Bayer, Bristol-Myers Squibb, Exelixis, Novartis,
and Pfizer; Motzer has received research funding from Bristol-Myers
Squibb, Eisai, Exelixis, GlaxoSmithKline, Novartis, and Pfizer, and has
received consultant/advisor fees from Eisai, Novartis, and Pfizer; Sharma
is in a leadership role with Evelo Therapeutics, Jounce Therapeutics, Kite
Pharma, and Neon Therapeutics, holds stock options with Evelo
Therapeutics, Jounce Therapeutics, Kite Pharma, and Neon Therapeutics,
has received consultant/advisor fees from Amgen, AstraZeneca, Bristol-
Myers Squibb, and GlaxoSmithKline, owns patents licensed to Bristol-
Myers Squibb, Jounce, and Merck, and has served as a principal
investigator for AstraZeneca, Bristol-Myers Squibb, and GlaxoSmithK-
line; Wagstaff has received honoraria and consultant/advisor fees from
and is on the speakers’ bureau for Bristol-Myers Squibb, MSD, Novartis,
Pfizer, and Roche, and has received travel accommodations from Bristol-
Myers Squibb and MSD; Plimack has received consultant/advisor fees
from Acceleron Pharma, Bristol-Myers Squibb, Dendreon, Genentech/
Roche, GlaxoSmithKline, Merck, Novartis, and Pfizer, has received
research funding from Acceleron Pharma, Bristol-Myers Squibb,
Dendreon, Genentech/Roche, GlaxoSmithKline, Merck, and Novartis,
and holds US patent number 14/588.503, filed January 2, 2015;
Hammers has received consultant/advisor fees from Bristol-Myers
Squibb, Cerulean, Exelixis, and Pfizer, and has received research funding
from Bristol-Myers Squibb, Exelixis, GlaxoSmithKline, Newlink, Pfizer
SFJ, and Tracon; Donskov has received research funding from
GlaxoSmithKline, Novartis, and Pfizer; Gurney has received consul-
tant/advisor fees from Astellas, Bristol-Myers Squibb, Novartis, and
Pfizer; Sosman has received honoraria and consultant/advisor fees from
Array, Genentech, Merck, and Novartis, and has received research
funding from BMD, Biomedical Valley Development, and GlaxoSmithK-
line; Zalewski has received consultant/advisor fees from Astellas,
Novartis, and Sanofi, and has received research funding from AstraZe-
neca, Bristol-Myers Squibb, Janssen, and Roche; Harmenberg is in a
leadership role with and has received consultant/advisor fees from
Glionova, Medivir, and Oncopeptides; holds stock options with Akinion,
Axelar, Medivir, Oncopeptides, and Oxypharma, has received research
funding from Bristol-Myers Squibb, and has received travel accom-
modations from Oncopeptides; McDermott has received consultant/
advisor fees from Array BioPharm, Bristol-Myers Squibb, Eisai, Exelixis,
Genentech BioOncology, Merck, Novartis, and Pfizer, and has received
research funding from Prometheus Laboratories; Choueiri has received
honoraria from NCCN and UpToDate, has received consultant/advisor
fees from Bayer, GlaxoSmithKline, Merck, Novartis, and Pfizer, and has
received research funding from AstraZeneca, Bristol-Myers Squibb,
Exelixis, GlaxoSmithKline, Genentech/Roche, Merck, Novartis, Peloton
Therapeutics, Pfizer, and TRACON Pharma; Tomita has received
honoraria from Novartis and Pfizer, has received consultant/advisor
fees from Novartis and Ono, and has received research funding from
Astellas, AstraZeneca, Pfizer, and Takeda; Ravaud has received honoraria
fromMSD, Novartis, and Pfizer; has received consultant/advisor fees and
travel accommodations from Bristol-Myers Squibb, Novartis, Pfizer, and
Roche, and has received research funding from Novartis and Pfizer;
Doan, Zhao, and Hardy are employed by and hold stock options with
Bristol-Myers Squibb; George (spouse) is employed by Amgen, has
received consultant/advisor fees from Astellas, Bayer, Bristol-Myers
Squibb, Exelixis, Novartis, Onclive, Pfizer, and Xcenda; and has received
research funding from Acceleron, Agensys, Bayer, Bristol-Myers Squibb,
Novartis, and Pfizer.
Funding/Support and role of the sponsor: This study was sponsored by
Bristol-Myers Squibb and Ono Pharmaceutical Co., Ltd. Authors received
no financial support or compensation for publication of this manuscript.
The funders contributed to the design and conduct of the study;
collection, management, analysis, and interpretation of the data; and
preparation, review, and approval of the manuscript in collaboration
with the investigators and authors of this report.
Acknowledgments: We thank the patients and their families, as well as
the investigators and participating study teams, for making this study
possible. All authors contributed and approved the manuscript;
professional medical writing and editorial assistance was provided by
Jennifer Granit and Lawrence Hargett of PPSI (a PAREXEL company),
funded by Bristol-Myers Squibb. This study was funded by Bristol-Myers
Squibb and Ono Pharmaceutical Co., Ltd.
Appendix A. Supplementary data
Supplementary data associated with this article can be
found, in the online version, at
.
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