Middleton, Mark R.
Dean, Emma
Evans, Thomas R. J.
Shapiro, Geoffrey I. http://orcid.org/0000-0002-3331-4095
Pollard, John
Hendriks, Bart S.
Falk, Martin
Diaz-Padilla, Ivan
Plummer, Ruth http://orcid.org/0000-0003-0107-1444
Funding for this research was provided by:
Vertex Pharmaceuticals (N/A, N/A, N/A, N/A, N/A, N/A, N/A, N/A)
Merck KGaA (N/A, N/A, N/A, N/A, N/A, N/A, N/A, N/A)
Article History
Received: 5 November 2020
Revised: 31 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, the Declaration of Helsinki and 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, and Institutional Review Board/Dana-Farber Cancer Institute.
: 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 outlicensed, 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.
: M.R.M. reports personal fees from Amgen, grants and personal fees from Roche, grants from AstraZeneca, grants and personal fees from GSK, personal fees and other from Novartis, other from Millenium, personal fees, non-financial support and other from Immunocore, personal fees and other from BMS, personal fees and other from Eisai, other from Pfizer, personal fees, non-financial support and other from Merck/MSD, personal fees and other from Rigontec (acquired by MSD), other from Regeneron, personal fees from BiolineRx, personal fees and other from Array Biopharma (now Pfizer), non-financial support and other from Replimune, personal fees from Kineta and personal fees from Silicon Therapeutics, outside the submitted work. E.D. was an employee of The University of Manchester and The Christie NHS Foundation Trust, Manchester, at the time of study; Current address: Oncology R&D, AstraZeneca, Cambridge and Alderley Park, UK. T.R.J.E. has received honoraria for speaking engagements and attending advisory boards paid to his institution, and support from Merck Sharp & Dohme to attend international medical conferences. 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 on behalf of 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. J.P. was an employee of Vertex Pharmaceuticals Europe Ltd, Abingdon, UK, at the time of manuscript preparation. He holds stock in Vertex Pharmaceuticals Inc. Current address: Bayer plc, Reading, UK. B.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 trial 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.
: Financial support for this study was initially provided by Vertex Pharmaceuticals Inc., Boston, MA, USA, and subsequently by Merck KGaA, Darmstadt, Germany. Medical writing assistance was provided by Alexander T. Hardy from Bioscript Stirling Ltd, Macclesfield, UK and funded by Merck KGaA, Darmstadt, Germany.