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consulting or advisory fees from Novartis, Eisai, and Pfizer, and research

funding from Exelixis, Bristol-Myers Squibb, Novartis, GlaxoSmithKline,

Eisai, and Pfizer. Katrina Peltola has received advisory fees from MSD,

Bristol-Myers Squibb, Lilly, Sanofi, Astellas, Pfizer, and Novartis, and travel

compensation from Pierre

[9_TD$DIFF]

Fabre and Bristol-Myers Squibb. Elizabeth

Plimack has received consulting or advisory fees from Merck, Dendreon,

Novartis, Bristol-Myers Squibb, Pfizer, GlaxoSmithKline, Acceleron

Pharma, and Genentech/Roche, and institutional research funding from

Merck, Bristol-Myers Squibb, GlaxoSmithKline, Acceleron Pharma,

Dendreon, Lilly, and AstraZeneca, and has an institutional interest in

US Patent No. 14/588.503.

[10_TD$DIFF]

Giuseppe Procopio has received grants from

Bayer and personal fees from Astellas, Bristol-Myers Squibb, Janssen,

Novartis, and Pfizer. Padmanee Sharma has received leadership fees from

Kite Pharma, Jounce, and Evelo; consultant or advisor fees from Bristol-

Myers Squibb, GlaxoSmithKline, AstraZeneca, and Amgen; investigator

fees from Bristol-Myers Squibb, GlaxoSmithKline, and AstraZeneca. She

has investment interests in Jounce, Kite Pharma, Evelo, and owns a patent

licensed to Jounce. Her spouse has received leadership fees from Kite

Pharma, Jounce, and Neon; has investment interests in Jounce, Kite, and

Neon; and has an interest in patents licensed to Bristol-Myers Squibb,

Jounce, and Merck. Jeffrey Sosman has received honoraria and consulting

or advisory fees fromNovartis, Genentech, Array, andMerck; and research

funding from

[11_TD$DIFF]

Bristol-Myers Squibb, Biomedical Valley Development, and

GlaxoSmithKline. Scott Tykodi has received consulting or advisory fees

from Prometheus Laboratories and Amgen, and institutional research

funding from Genentech, Bristol-Myers Squibb, Exelixis, Argos Therapeu-

tics, GlaxoSmithKline, and Prometheus. An immediate family member of

John Wagstaff has received honoraria from Roche, Bristol

[12_TD$DIFF]

-Myers

[13_TD$DIFF]

Squibb,

Pfizer, Novartis, andMSD; consulting or advisory fees fromRoche, Bristol

[12_TD$DIFF]

-

Myers

[13_TD$DIFF]

Squibb, Pfizer, Novartis, and MSD; and travel and

[14_TD$DIFF]

accommodation

expenses from Bristol-Myers Squibb and MSD. Ian Waxman and Huanyu

Zhao are employed by and hold stock in Bristol-Myers Squibb. Daniel

Castellano, Sandhya Srinivas, and Takeshi Ueda have nothing to disclose.

Funding/Support and role of the sponsor:

This study was sponsored by

Bristol-Myers Squibb and Ono Pharmaceutical Company Limited. The

sponsors 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. Medical writing assistance was provided by Jennifer Granit of

PPSI (a PAREXEL company) and was funded by Bristol-Myers Squibb.

Appendix A. Supplementary data

Supplementary data associated with this article can be

found, in the online version, at

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

.

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