Hu-Lieskovan, Siwen
Braiteh, Fadi
Grilley-Olson, Juneko E. http://orcid.org/0000-0002-1896-7020
Wang, Xiao
Forgie, Alison
Bonato, Vinicius http://orcid.org/0000-0003-2807-5859
Jacobs, Ira A.
Chou, Jeffrey http://orcid.org/0000-0001-9232-0092
Johnson, Melissa L. http://orcid.org/0000-0001-9874-1314
Clinical trials referenced in this document:
Documents that mention this clinical trial
Association of Tumor Mutational Burden and Immune Gene Expression with Response to PD-1 Blockade by Sasanlimab Across Tumor Types and Routes of Administration
https://doi.org/10.1007/s11523-021-00833-2
Funding for this research was provided by:
Pfizer
Article History
Accepted: 2 August 2021
First Online: 25 October 2021
Declarations
:
: This study was sponsored by Pfizer.
: S. Hu-Lieskovan disclosed consulting honoraria from Amgen, Genmab, Xencor, and Merck; research funding from Bristol Myers Squibb, Merck, and Vaccinex. F. Braiteh disclosed speaker bureau and advisory board honoraria from Pfizer. J. E. Grilley-Olson disclosed no relevant conflict of interest. X. Wang, A. Forgie, V. Bonato, I. A. Jacobs, and J. Chou were employees of and owned stock in Pfizer Inc. at the time of this study. ML Johnson disclosed institutional research funding from AbbVie, Adaptimmune, Amgen, Apexigen, Arcus Biosciences, Array BioPharma, Artios Pharma, AstraZeneca, ATRECA, BeiGene, BerGenBio, Birdie Pharmaceuticals/Seven and Eight Biopharmaceuticals, Boehringer Ingelheim, Calithera Biosciences, Checkpoint Therapeutics, Corvus, Curis, CytomX, Daiichi-Sankyo, Dracen Pharmaceuticals, Dynavax, EMD Serono, Genentech/Roche, Genmab, Genocea, GlaxoSmithKline, Gritstone Oncology, Harpoon Therapeutics, Hengrui Therapeutics, Immunocore, Incyte, Janssen, Lilly, Loxo Oncology, Lycera, Merck, Mirati Therapeutics, Neovia, Novartis, Pfizer, PMV Pharmaceuticals, Regeneron, Ribon Therapeutics, Sanofi, Shattuck Labs, Silicon Therapeutics, Stemcentrx, Syndax, Takeda, Tarveda Therapeutics, TCR2 Therapeutics, TMUNITY Therapeutics, University of Michigan, and WindMIL Therapeutics; spouse role as contract lobbyist for Astellas and Otsuka Pharmaceuticals; and consulting honoraria (to institution) from AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Calithera, Celgene, Daiichi Sankyo, Editas Medicine, Eisai, EMD Serono, G1 Therapeutics, Genentech/Roche, GlaxoSmithKline, Gritstone Oncology, Ideaya Biosciences, Incyte, Janssen, Lilly, Loxo Oncology, Merck, Mirati Therapeutics, Novartis, Pfizer, Ribon Therapetics, Sanofi and WindMIL Therapeutics.
: The study was approved by the institutional review board or independent ethics committee of the participating institutions and followed the Declaration of Helsinki and the International Conference on Harmonisation Good Clinical Practice guidelines.
: All patients provided written informed consent.
: Not required.
: Upon request, and subject to certain criteria, conditions, and exceptions (see ExternalRef removedfor more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines, and medical devices (1) for indications that have been approved in the US and/or EU or (2) in programs that have been terminated (i.e., development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.
: Not applicable.
: All authors contributed to data analysis and interpretation for this study as well as manuscript development. All authors read and approved the final manuscript.