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Article History

First Online: 10 November 2020

Declarations

:

: This study was sponsored by Merck Serono S.A. (Geneva, Switzerland), an affiliate of Merck KGaA, Darmstadt, Germany. Representatives of Merck KGaA participated in the study design; the collection, analysis, and interpretation of the data; and the development and submission of this manuscript.

: J.-P. Delord has received consulting fees or honoraria from MSD, Bristol Myers Squibb, Novartis, Roche, and Genentech. A. Italiano has received research funding from AstraZeneca, Bayer, Chugai, Merck, MSD, Pharmamar, and Roche; consulting fees or honoraria from AstraZeneca, Bayer, Roche, and Springworks; and reimbursement for travel from AstraZeneca and Roche. A. Awada has received research funding from MSD and Roche and has participated on advisory boards for Roche, Lilly, Puma Technology, Pfizer, Eisai Europe, Genoscience Pharma, Merck, Sopa Diagnostics, Bayer, Clovis Oncology, and Daiichi-Sankyo and speaker bureaus for Lilly. C. Lebbé has received research funding from Roche, MSD, Bristol Myers Squibb, and Novartis; reimbursement for travel from Bristol Myers Squibb; and has served on speaker bureaus for Roche, MSD, Bristol Myers Squibb, Novartis, Pierre Fabré, and Sanofi. T. Lesimple has received research funding from Roche and reimbursement for travel or review activities from Bristol Myers Squibb, MSD, Novartis, and Pierre Fabré Oncology. J.H.M Schellens has received research funding from Debiopharm and is a shareholder and employee of Modra Pharmaceuticals BV. R. Kefford has received reimbursement for travel from Amgen. S. Faivre has received consulting fees or honoraria from Blueprint, Bristol Myers Squibb, Bayer, Ipsen, EMD Serono, MSD, and Roche. A. Schueler and G. Massimini are employees and shareholders of Merck KGaA, Darmstadt, Germany. E. Raymond has received consulting fees or honorarium from Genoscience Pharma and SCOR and is a shareholder of Genoscience Pharma and SCOR. P. Aftimos, N. Houédé, C. Pages, M. Dinulescu, S. Leijen, S. Rottey, V. Kruse, and C. Gomez-Roca have no conflicts of interest that are directly relevant to the content of this article.

: Study concept: SF, GM, ER. Study design: SF, GM, ER, JHMS. Data acquisition: NH, CP, TL, SL, SR, VK, SF, PA, ER. Quality control of data and algorithms: NH, SR. Data analysis and interpretation: NH, TL, JHMS, SR, SF, PA, AS, GM, ER. Statistical analysis: AS. Manuscript preparation: TL, GM, ER. Manuscript editing: PA, JHMS, SR, SF, GM, ER. Manuscript review: J-PD, AI, AA, PA, NH, CL, CP, TL, MD, JHMS, SL, SR, VK, RK, SF, CG-R, AS, GM, ER.

: Any requests for data by qualified scientific and medical researchers for legitimate research purposes will be subject to Merck KGaA’s Data Sharing Policy. All requests should be submitted in writing to Merck KGaA's data sharing portal (). When Merck KGaA 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 will endeavor to gain agreement to share data in response to requests.

: The protocol was approved and registered with the appropriate regulatory authorities, and the study was performed in accordance with the Declaration of Helsinki, Good Clinical Practice, and applicable regulatory requirements.