Shapiro, Geoffrey I. http://orcid.org/0000-0002-3331-4095
Wesolowski, Robert
Devoe, Craig
Lord, Simon http://orcid.org/0000-0001-7946-5609
Pollard, John
Hendriks, Bart S.
Falk, Martin
Diaz-Padilla, Ivan
Plummer, Ruth
Yap, Timothy A. http://orcid.org/0000-0002-2154-3309
Funding for this research was provided by:
Merck KGaA (N/A, N/A, N/A, N/A, N/A, N/A, N/A, N/A, N/A)
Vertex Pharmaceuticals (N/A, N/A, N/A, N/A, N/A, N/A, N/A, N/A)
Article History
Received: 5 November 2020
Revised: 22 March 2021
Accepted: 15 April 2021
First Online: 26 May 2021
Ethics approval and consent to participate
: The study was conducted in accordance with the ethical principles of the International Council for Harmonization guideline for Good Clinical Practice and the Declaration of Helsinki, and with applicable local regulations. All patients provided written informed consent before any study procedures were performed. The study sites received ethical approval from the following institutional review boards/independent ethical committees: NRES Committee North East—Sunderland, London—Surrey Borders Research Ethics Committee, Institutional Review Board/Dana Farber Cancer Institute, Western Institutional Review Board, and Biomedical Research Alliance of New York, LLC/Institutional Review Board.
: Not applicable.
: Any requests for data by qualified scientific and medical researchers for legitimate research purposes will be subject to the Merck KGaA, Darmstadt, Germany Data Sharing Policy. All requests should be submitted in writing to the Merck KGaA, Darmstadt, Germany data-sharing portal (ExternalRef removed). When Merck KGaA, Darmstadt, Germany has a co-research, co-development, or co-marketing or co-promotion agreement, or when the product has been out-licensed, the responsibility for disclosure might be dependent on the agreement between parties. Under these circumstances, Merck KGaA, Darmstadt, Germany will endeavour to gain agreement to share data in response to requests.
: G.I.S. has received research funding from Eli Lilly, Merck KGaA/EMD Serono, Merck & Co., Inc., and Sierra Oncology; and honoraria for serving 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, Boehringer Ingelheim, ImmunoMet, Artios, and Asana. R.W. has received research funding from Acerta Pharma and AstraZeneca; served on advisory boards for Puma Biotechnology, Pfizer; and served on speakers’ bureau for Roche Diagnostics. C.D. reports honoraria for serving on advisory boards on behalf of Pfizer. S.L. reports personal fees from Eisai, Shionogi, and Prosigna, and was previously employed by Pfizer. J.P. was an employee of Vertex Pharmaceuticals Europe Ltd, Abingdon, UK, at the time of manuscript preparation; and holds stock in Vertex Pharmaceuticals Inc. Current address: Bayer plc, Reading, UK. B.S.H. was an employee of EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, Darmstadt, Germany, at the time of manuscript preparation. Current address: Novartis Institutes for BioMedical Research, Cambridge, MA, USA. M.F. was an employee of Merck KGaA, Darmstadt, Germany, at the time of manuscript preparation. Current address: CureVac, Tübingen, Germany. I.D.-P. was an employee of Ares Trading SA, Eysins, Switzerland, an affiliate of Merck KGaA, Darmstadt, Germany, at the time of manuscript preparation. Current address: GlaxoSmithKline, Zug, Switzerland. R.P. reports honoraria for serving on advisory boards on behalf of Vertex and Merck KGaA relating to this compound; reimbursement for her institution for clinical trials costs; consultancy services to Pierre Faber, Bayer, Octimet, Clovis Oncology, Novartis, Karus Therapeutics, Biosceptre, BMS, Cybrexa, Ellipses, CV6 Therapeutics, Astex Therapeutics, and Sanofi Aventis; and research funding from AstraZeneca. T.A.Y. is employed as a Medical Director of the Institute for Applied Cancer Science, which has a commercial interest in DDR and other inhibitors; has received research support from AstraZeneca, Bayer, Clovis, Constellation, Cyteir, Eli Lilly, EMD Serono, Forbius/Formation Biologics, F-Star, GlaxoSmithKline, Genentech, ImmuneSensor, Ipsen, Jounce, Karyopharm, Kyowa, Novartis, Pfizer, Ribon Therapeutics, Regeneron, Sanofi, Seattle Genetics, Tesaro, and Vertex Pharmaceuticals; and has provided consultancy services for Almac, Aduro, AstraZeneca, Atrin, Axiom, Bayer, Calithera, Clovis, Cybrexa, EMD Serono, F-Star, Guidepoint, Ignyta, I-Mab, Jansen, Kyn Therapeutics, Merck, Pfizer, Roche, Seattle Genetics, and Zai Labs.
: Financial support for this study was provided by Merck KGaA, Darmstadt, Germany and Vertex Pharmaceuticals Inc., Boston, MA, USA. Medical writing assistance was provided by David Lester of Bioscript Stirling Ltd, Macclesfield, UK, and funded by Merck KGaA, Darmstadt, Germany.