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Article History

Received: 9 October 2021

Revised: 20 November 2021

Accepted: 1 December 2021

First Online: 9 December 2021

Ethics approval and consent to participate

: The clinical trial was approved by the NCI Central Institutional Review Board (CIRB) and the US Food and Drug Administration (NCT02898207). All procedures involving human participants were carried out in accordance with the Declaration of Helsinki. Written informed consent was obtained from patients or guardians before enrolment in the study.

: Not applicable.

: Dr. Konstantinopoulos has participated in advisory boards for Alkermes, AstraZeneca, GSK, BMS, Repare, Artios and Kadmon, serves in the gynaecologic oncology scientific committee for AstraZeneca and has received institutional support as P.I. of clinical trials from AstraZeneca, Bayer, Eli Lilly, GSK, Merck, Merck KGaA, Pfizer and GSK. Dr. Cloud Paweletz has sponsored research agreements with Daiichi Sankyo, Bicycle Therapeutics, Transcenta, Bicara Therapeutics, AstraZeneca, Intellia Therapeutics, Janssen Pharmaceuticals, Array Biopharma, has stock and other ownership Interests in XSphera Biosciences, has received honoraria from Bio-Rad and ThermoFisher and has consulting or advisory role for DropWorks and XSphera Biosciences. Dr. Liu has participated in advisory boards from AstraZeneca, Clovis, Eisai, EpsilaBio, Genentech, GSK/Tesaro, Regeneron Pharmaceuticals and has received institutional support as P.I. of clinical trials from 2X Oncology, Aravive, Arch Oncology, AstraZeneca, Bristol-Myers Squibb, Clovis Oncology, CytomX Therapeutics, GlaxoSmithKline, Regeneron, Surface Oncology, Tesaro, Vigeo therapeutics. Dr. Campos has participated in the advisory board for AstraZeneca. Dr. Wright has participated in the advisory board for GSK. Dr. Matulonis has participated in advisory boards for Novartis, Blueprint Medicines, Trillium, in data safety monitoring boards for Advaxis and Symphogen and has been a consultant for NextCure, Astrazeneca and Merck. Dr. D’Andrea is a consultant/advisory board member for Lilly Oncology, Merck-EMD-Serono, Intellia Therapeutics, Sierra Oncology, Cyteir Therapeutics, Third Rock Ventures, AstraZeneca, Ideaya Inc., Cedilla Therapeutics Inc., a stockholder in Ideaya Inc., Cedilla Therapeutics Inc., and Cyteir, and reports receiving commercial research grants from Lilly Oncology and Merck-EMD-Serono. Dr. Shapiro has received research funding from Eli Lilly, Merck KGaA/EMD-Serono, Merck, and Sierra Oncology, has served on advisory boards for Pfizer, Eli Lilly, G1 Therapeutics, Roche, Merck KGaA/EMD-Serono, Sierra Oncology, Bicycle Therapeutics, Fusion Pharmaceuticals, Cybrexa Therapeutics, Astex, Almac, Ipsen, Bayer, Angiex, Daiichi Sankyo, Seattle Genetics, Boehringer Ingelheim, ImmunoMet, Asana, Artios, Atrin, Concarlo Holdings, Syros, Zentalis, CytomX Therapeutics and Blueprint Medicines and holds a patent entitled, “Dosage regimen for sapacitabine and seliciclib,” also issued to Cyclacel Pharmaceuticals, and a pending patent, entitled, “Compositions and Methods for Predicting Response and Resistance to CDK4/6 Inhibition,” together with Liam Cornell.