Geynisman, Daniel M.
Burotto, Mauricio
Porta, Camillo
Suarez, Cristina
Bourlon, Maria T.
Huo, Stephen
Del Tejo, Viviana
Du, Ella X.
Yang, Xiaoran
Betts, Keith A.
Choueiri, Toni K.
McGregor, Bradley http://orcid.org/0000-0002-8298-0289
Funding for this research was provided by:
Bristol-Myers Squibb
Article History
Accepted: 16 May 2022
First Online: 13 June 2022
Declarations
:
: Financial support for this research was provided by Bristol Myers Squibb. The study sponsor was involved in several aspects of the research, including the study design, the interpretation of data, the writing of the manuscript, and the decision to submit the manuscript for publication.
: Stephen Huo and Viviana Del Tejo are employees of Bristol Myers Squibb, which funded the development and conduct of this study and manuscript. Ella X. Du, Xiaoran Yang, and Keith A. Betts are employees of Analysis Group, Inc., a consulting company that has provided paid consulting services to Bristol Myers Squibb. Daniel M. Geynisman received consulting fees from Pfizer, Exelixis, AstraZeneca, Seattle Genetics/Astellas, Eisai, Merck, Myovant Sciences, and 2nd.MD, as well as research funding from Genentech, Merck, Calithera Biosciences, Astellas Pharma, and Harpoon therapeutics. Mauricio Burotto received consulting fees from Roche/Genentech, Bristol Myers Squibb, MSD Oncology, Novartis, and AstraZeneca, as well as honoraria from Roche/Genentech, MSD Oncology, Bristol Myers Squibb, and AstraZeneca. Camillo Porta received consulting fees from Angelini Pharma, AstraZeneca, Bristol Myers Squibb, Eisai, EUSA Pharma, Ipsen, Merck Serono, and MSD, as well as honoraria from Bristol Myers Squibb, EUSA Pharma, General Electric, Ipsen, and MSD, payment for expert testimony from EUSA Pharma and Pfizer, and fees for attending meetings/travel from Roche. Cristina Suarez received research funding from AB Science, Aragon Pharmaceuticals, Astellas Pharma, AstraZeneca, Bayer, Blueprint Medicines, Boehringer Ingelheim España, Bristol Myers Squibb, Clovis Oncology, Exelixis, Genentech, GlaxoSmithKline, Hoffmann-La Roche, Novartis, Pfizer, and Sanofi-Aventis, as well as honoraria from Astellas Pharma, Bristol Myers Squibb, Hoffmann-La Roche, Ipsen, and Pfizer, and scientific advisory fees from Astellas Pharma, Bayer, Bristol Myers Squibb, EUSA Pharma, Hoffmann-La Roche, Ipsen, MSD, Novartis, Pfizer, and Sanofi-Aventis. Maria T. Bourlon received consulting fees from Bristol Myers Squibb, Asofarma, Eisai, MSD Oncology, Janssen Oncology, Novartis, Bayer, Ferring, as well as honoraria from Asofarma, MSD Oncology, Bristol Myers Squibb, Bayer, Eisai, Janssen Oncology, Ipsen, Pfizer, Merck, Ferring, Tecnofarma, Medicamenta, AstraZeneca, and Astellas Pharma, payment for expert testimony from Asofarma, support for attending meetings/travel from Asofarma, Janssen-Cilag, MSD Oncology, Bristol Myers Squibb Mexico, Pfizer, Ipsen, and Sanofi, and steering committee honoraria from Bristol Myers Squibb. Toni K. Choueiri participated in Data Safety Monitoring/Advisory Boards and received grants/contracts and consulting fees from AstraZeneca, Aravive, Aveo, Bayer, Bristol Myers Squibb, Calithera, Circle Pharma, Eisai, EMD Serono, Exelixis, GlaxoSmithKline, IQVIA, Infinity, Ipsen, Janssen, Kanaph, Lilly, Merck, Nikang, Nuscan, Novartis, Pfizer, Roche, Sanofi/Aventis, Surface Oncology, Takeda, Tempest, and UpToDate, and declares a leadership or fiduciary role in NCCN, GU Steering Committee, and ASCO/ESMO, owning stock or stock options in Pionyr, Tempest, Osel, and NuscanDx, institutional patents filed on molecular mutations and immunotherapy response, and ctDNA, medical writing and editorial assistance support which may have been funded in part by Communications companies, mentoring several non-US citizens on research projects with potential funding (in part) from non-US sources/Foreign Components, and receiving independent funding of drug companies or/and royalties potentially involved in research around the subject matter. Bradley McGregor received consulting fees from Exelixis, Bristol Myers Squibb, Pfizer, Seattle Genetics, Calithera, EMD Serono, Eisai, Asetellas, Dendreon, Nektar, and Bayer, as well as research funding from Exelixis, Bristol Myers Squibb, Pfizer, Seattle Genetics, and Calithera.
: CheckMate 9ER was approved by the institutional review board or ethics committee at each site and conducted in accordance with Good Clinical Practice guidelines per the International Conference on Harmonisation. All patients provided written informed consent based on Declaration of Helsinki principles.
: Not applicable. This a post-hoc analysis of previously collected, de-identified data.
: Not applicable.
: Code is not available for sharing.
: Data are available upon reasonable request. Bristol Myers Squibb’s policy on data sharing may be found at ExternalRef removed. De-identified and anonymized datasets of clinical trial information, including patient-level data, will be shared with external researchers for proposals that are complete, for which the scientific request is valid and the data are available, consistent with safeguarding patient privacy and informed consent.
: All authors were involved in the conception and design, and/or analysis and interpretation of the data; the drafting of the paper and revising it critically for intellectual content; and the final approval of the version to be published. All authors agree to be accountable for all aspects of the work.