Document is current

Article History

Accepted: 5 October 2021

First Online: 23 October 2021

Declarations

:

: This trial was sponsored by Pfizer as part of an alliance between Pfizer and Merck. Medical writing support was provided by Irene Minkina of ClinicalThinking and was funded by Pfizer and Merck.

: EAH has received honoraria for advisory work for Roche, Bristol Myers Squibb, Celgene, MSD, Gilead, Antigene, Janssen, and AstraZeneca; travel expenses and honoraria for speaker work for Roche; and research funding from Roche, Merck, Bristol Myers Squibb, Celgene, MSD, Gilead, Antigene, Janssen, and AstraZeneca. TP has acted in consultancy/advisory roles for AbbVie, ADC Therapeutics, AstraZeneca, Bayer, BeiGene, Bristol Myers Squibb, Celgene, Incyte, Genentech, Gilead, Kite, and Pharmacyclics and has received research funding from AbbVie, Bayer, BMS/Celgene, Genentech, and Incyte. AS has acted in consultancy/advisory roles for Bristol Myers Squibb, Servier, Gilead, Pfizer, Eisai, Bayer, MSD, Arqule, and Sanofi and has undertaken speaker bureau work for Takeda, Bristol Myers Squibb, Roche, AbbVie, Amgen, Celgene, Servier, Gilead, AstraZeneca, Pfizer, Arqule, Lilly, Sandoz, Eisai, Novartis, Bayer, and MSD. NSS has acted in consultancy/advisory roles for Kite, AbbVie, Janssen, and Kyowa Kirin and has undertaken speaker bureau work for Janssen and AbbVie. GPG has acted in advisory roles for Roche, Novartis, Gilead, and Janssen; and has received honoraria from Roche, AbbVie, and Novartis and research funding from MSD, BeiGene, and Janssen. JR has acted in consultancy/advisory roles for Takeda, Bristol Myers Squibb, ADC Therapeutics, and Novartis; owns stock in AstraZeneca and ADC Therapeutics; has received honoraria from Takeda, ADC Therapeutics, and Bristol Myers Squibb; has provided speaker/expert testimony for Takeda and ADC Therapeutics; and has received research funding from Takeda. KG has received honoraria from and served as a consultant for Amgen, AbbVie, BMS/Celgene, Janssen, Sanofi-Genzyme, Takeda, Novartis, Pfizer, Sandoz, and BeiGene and has received research funding from Amgen, AbbVie, BMS/Celgene, Janssen, Sanofi-Genzyme, Takeda, and Novartis. AT, BH, ADL, and RS are employees of and report stock ownership in Pfizer. SMA has received research funding (paid to his institution) for clinical trials from Bristol Myers Squibb, Seattle Genetics, Takeda, AI Therapeutics, Affimed, Pfizer, Trillium, Regeneron, and ADC Therapeutics. LEB, FR, GV, FO, CQ, and DS have no conflicts of interest that are directly relevant to the content of this article.

: Upon request, and subject to certain criteria, conditions and exceptions (see  for 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 USA 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.

: This study was approved by the relevant institutional review boards or ethics committees of all participating centers and conducted in accordance with the principles of the Declaration of Helsinki.

: All patients provided written informed consent.

: EAH, TP, LEB, AS, NSS, FR, GPG, JR, KG, and ADL collected, assembled, analyzed, and interpreted the data. GV collected and assembled the data. FO, BH, and SMA conceived and designed the study and collected, assembled, analyzed, and interpreted the data. CQ and DS collected and assembled the data. AT conceived and designed the study and analyzed and interpreted the data. RS analyzed and interpreted the data. All authors were involved in writing the article and approved the final version.