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Article History

Received: 19 November 2020

Accepted: 2 March 2021

First Online: 8 March 2021

Declarations

:

: All procedures performed in studies involving human participants were performed in accordance with the Declaration of Helsinki and International Council for Harmonization Good Clinical Practice guidelines with registration of NCT02784795.

: Written informed consent was obtained from all individual participants included in the study.

: Not applicable.

: A Azaro, Advisory and Consulting: Amcure GmbH and Orion Corporation. C Massard, Advisory and Consulting: Amgen, Astellas, AstraZeneca, Bayer, BeiGene, BMS, Celgene, Debiopharm, Genentech, Ipsen, Janssen, Lilly, MedImmune, MSD, Novartis, Pfizer, Roche, Sanofi, and Orion; Principal/Sub-Investigator of Clinical Trials: Abbvie, Aduro, Agios, Amgen, Argen-x, Astex, AstraZeneca, Aveo pharmaceuticals, Bayer, Beigene, Blueprint, BMS, Boehringer Ingelheim, Celgene, Chugai, Clovis, Daiichi Sankyo, Debiopharm, Eisai, Eos, Exelixis, Forma, Gamamabs, Genentech, Gortec, GSK, H3 biomedecine, Incyte, Innate Pharma, Janssen, Kura Oncology, Kyowa, Lilly, Loxo, Lysarc, Lytix Biopharma, Medimmune, Menarini, Merus, MSD, Nanobiotix, Nektar Therapeutics, Novartis, Octimet, Oncoethix, Oncopeptides AB, Orion, Pfizer, Pharmamar, Pierre Fabre, Roche, Sanofi, Servier, Sierra Oncology, Taiho, Takeda, Tesaro, and Xencor, outside of submitted work. WD Tap, Advisory Boards: Eli Lilly and Company, EMD Serono, Eisai, Janssen, Immune design, Daiichi Sankyo, Blueprint, Loxo, Glaxo Smith Kline, Agios Pharmaceuticals, NanoCarrier, Deciphera, and C4 Therapeutics; Consulting: Daiichi Sankyo, FDA ODAXC Meeting Pexidartinib; Scientific Advisory Board: Certis Oncology Solutions (and stock ownership); Co-founder of Atropos Therapeutics (and stock ownership); Patent (pending) on the identification and development of biomarkers for CDK4 inhibitors in cancer. PA Cassier, received honoraria from Amgen, AstraZeneca, Blueprint Medicines, Novartis, Roche/Genentech, and Merck Serono; Investigator/Sub-Investigator of Clinical Trials: Abbvie, AstraZeneca, Bayer, Blueprint Medicines, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Glaxo Smith Kline, Innate Pharma, Janssen, Merck Serono, Merck Sharp Dohme, Novartis, Plexxikon, Genentech/Roche, Taiho Pharmaceuticals, and Transgene, outside of submitted work; Travel Accommodations and Expenses: Amgen, Bristol-Myers Squibb, Merck Sharp and Dohme, Netris Pharma, Novartis, and Roche. J Merchan, Advisory and Consulting: Exelixis; Investigator/Sub-Investigator of Clinical Trials: Eli Lilly and Company, Pfizer, Novartis, Genentech, Merck, Peloton Therapeutics, Corvus Pharmaceuticals, Tizona Therapeutics, Vyriad, Sillagen, Replimune, Seattle Genetics, Eisai, Calithera Biosciences, and Rexahn Pharmaceuticals, outside of the submitted work. A Italiano, Advisory: Bayer, Daiichi Sankyo, Merck, Roche, and Springworks; Grants: Bayer, Chugai, Pharmamar, MSD, Roche, and Merck. K Benhardji, Patents: LY3039478 related patents; S Pant, Advisory and Consulting: Tyme, Inc., 4D-Pharma, Xencor, Ipsen; Principal/Sub-Investigator for Clinical Trials: Arcus, Arqule, Bristol-Myers Squibb, Eli Lilly and Company, Five Prime Therapeutics, Glaxo Smith Kline, Holy Stone Healthcare Co., Tyme, Inc., Ipsen, Mirati Therapeutics, Inc., Novartis, Onco Response, Red Hill Biopharma, Ltd., Rgenix, Sanofi-Aventis, Xencor, Astellas, and Janssen, outside of submitted work. B Anderson, E Yuen, D Yu, G Oakley III, and KA Benhadji are current or past employees of Eli Lilly and Company and may hold company stocks. B Anderson is an employee of PRA Health Sciences and K Benhadji is an employee of Taiho Oncology, and may hold company stocks.