Article Information
Accepted for Publication: July 9, 2021.
Published Online: October 14, 2021. doi:10.1001/jamaoncol.2021.4761
Open Access: This is an open access article distributed under the terms of the
CC-BY-NC-ND License. © 2021 Zhou C et al.
JAMA Oncology.
Corresponding Author: Caicun Zhou, PhD, MD, Department of Oncology, Shanghai Pulmonary Hospital, 507 Zhengmin
Rd, Yangpu District, Shanghai 200433, China (
caicunzhoudr@
123456163.com
).
Author Contributions: Dr Zhou had full access to all of the data in the study and takes responsibility
for the integrity of the data and the accuracy of the data analysis.
Concept and design: Ramalingam, Riely, J. Lin, Mehta.
Acquisition, analysis, or interpretation of data: Zhou, T. Kim, S. Kim, Yang, Riely, Mekhail, Nguyen, Garcia Campelo, Felip, Vincent,
Jin, Griffin, Bunn, J. Lin, H. Lin, Mehta, Jänne.
Drafting of the manuscript: Zhou, Garcia Campelo, Jin, Mehta, Jänne.
Critical revision of the manuscript for important intellectual content: Zhou, Ramalingam, T. Kim, S. Kim, Yang, Riely, Mekhail, Nguyen, Garcia Campelo, Felip,
Vincent, Jin, Griffin, Bunn, J. Lin, H. Lin, Mehta.
Statistical analysis: Bunn, J. Lin, H. Lin.
Administrative, technical, or material support: Zhou, Ramalingam, T. Kim, S. Kim, Riely, Felip, Jin, Jänne.
Supervision: Zhou, Ramalingam, Yang, Nguyen, J. Lin, Mehta.
Other—scientific oversight: Vincent.
Conflict of Interest Disclosures: Dr Zhou reported personal fees for lecturing from Eli Lilly China, Sanofi, Roche,
Merck Sharp & Dohme, Qilu, Hengrui, Innovent Biologics, Luye Pharma, TopAlliance Biosciences
Inc, Amoy Diagnostics, and CStone Pharmaceuticals outside the submitted work. Dr Ramalingam
reported grants to institution and personal fees from Takeda for participation in
advisory board meeting during the conduct of the study; grants to institution from
AstraZeneca, Bristol Myers Squibb, Merck, GlaxoSmithKline, and Genmab; and personal
fees for serving on scientific advisory boards from Eisai and GlaxoSmithKline outside
the submitted work. Dr T. Kim reported grants from AstraZeneca-Korea Health Industry
Development Institute and honoraria or advisory role from AstraZeneca, Boryung, F.
Hoffmann-La Roche Ltd/Genentech, Inc, Novartis, Sanofi, and Takeda outside the submitted
work. Dr Yang reported grants and personal fees (advisory board) from AstraZeneca;
other to institution (advisory board) from Bayer, Janssen, and GlaxoSmithKline; personal
fees (advisory board) from Roche, Novartis, Bristol Myers Squibb, and Ono Pharmaceuticals;
and personal fees (advisory board) and other to institution (advisory board) from
Amgen, Boehringer Ingelheim, Lilly, Pfizer, Merck Sharp & Dohme, Merck, Takeda, Yuhan,
and Daiichi Sankyo outside the submitted work. Dr Riely reported grant funding for
clinical trial conduct as well as editorial support for manuscript and presentation
preparation from Takeda and grants from National Cancer Institute during the conduct
of the study; nonfinancial support (provision of investigational agent for another
clinical trial) from Takeda; and grants from Roche, Merck, Novartis, Pfizer, and Mirati
outside the submitted work. Dr Mekhail reported personal fees from Takeda outside
the submitted work. Dr Garcia Campelo reported personal fees from Takeda during the
conduct of the study; personal fees from Bristol Myers Squibb, Lilly, Merck Sharp
& Dohme, Janssen, Roche, Novartis, and Pfizer outside the submitted work. Dr Felip
reported personal fees (advisory board) from AbbVie, Amgen, Bayer, Blueprint Medicines,
GSK, Janssen, Merck KGaA, Puma Biotechnology, Sanofi Genzyme, Beigene, Medical Trends,
Peptomyc, Regeneron, and Syneos Health; personal fees (speakers bureau) from Medscape,
PeerVoice, Springer, prIME Oncology, Touch Medical, and CME Outfitters; personal fees
(advisory board and speakers bureau) from AstraZeneca, Boehringer Ingelheim, Bristol
Myers Squibb, Eli Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Takeda, and Roche;
grants from Grant for Oncology Innovation (GOI) and Fundación Merck Salud; and serving
as an independent member of the board for Grífols outside the submitted work. Drs
Vincent, H. Lin, Mehta, and Bunn, and Ms Jin reported being employees of Millennium
Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited,
during the conduct of the study. Dr Jänne reported grants (sponsored research) and
personal fees (consulting on drug development) from Takeda Oncology during the conduct
of the study; grants (sponsored research) from Daiichi Sankyo, Puma Biotechnology,
Astellas, and Revolution Medicines; grants (sponsored research) and personal fees
(consulting on drug development) from AstraZeneca, Boehringer Ingelheim, and Eli Lilly;
personal fees (consulting on drug development) from Roche/Genentech, Chugai Pharmaceuticals,
Ignyta, Loxo Oncology, SFJ Pharmaceuticals, Voronoi, Daiichi Sankyo, Biocartis, Novartis,
Sanofi, Mirati Therapeutics, Transcenta, Silicon Therapeutics, Syndax, Nuvalent, Bayer,
Eisai, Allorion Therapeutics, Accutar Biotech, and AbbVie outside the submitted work;
in addition, Dr Jänne had a patent for
EGFR mutations licensed to Lab Corp, receiving postmarketing royalties from Dana-Farber
Cancer Institute–owned intellectual property on
EGFR mutations licensed to Lab Corp. No other disclosures were reported.
Funding/Support: The study was funded by
Millennium Pharmaceuticals, Inc, Cambridge, Massachusetts, a wholly owned subsidiary of
Takeda Pharmaceutical Company Limited.
Role of the Funder/Sponsor: This study was supported by Millennium Pharmaceuticals, Inc, Cambridge, Massachusetts,
a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. The sponsor designed
and conducted the study and collected the data together with the authors. The sponsor
managed and analyzed the data. Data were interpreted by the authors and the sponsor.
The sponsor together with the authors prepared, reviewed, and approved the manuscript
and made the decision to submit the manuscript for publication.
Additional Contributions: The authors would like to thank the patients, their families, and their caregivers;
the study investigators and their team members at each study site; and colleagues
from Millennium Pharmaceuticals, Inc, Cambridge, Massachusetts, a wholly owned subsidiary
of Takeda Pharmaceutical Company Limited. Professional medical writing assistance
was provided by Amy Zannikos, PharmD, and Lela Creutz, PhD, of Peloton Advantage,
LLC, an OPEN Health company, Parsippany, New Jersey, and funded by Millennium Pharmaceuticals,
Inc.