Tan, Benjamin
Khattak, Adnan
Felip, Enriqueta
Kelly, Karen
Rich, Patricia
Wang, Ding
Helwig, Christoph
Dussault, Isabelle
Ojalvo, Laureen S.
Isambert, Nicolas
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Funding for this research was provided by:
Merck KGaA
GlaxoSmithKline
Article History
Accepted: 19 March 2021
First Online: 19 May 2021
Declarations
:
: This trial was funded by Merck KGaA, Darmstadt, Germany, and is part of an alliance between Merck KGaA and GlaxoSmithKline. Merck KGaA provided the study drug and worked with investigators on the trial design and plan, collection and analysis of data, and interpretation of results. Funding for a professional medical writer with access to the data was provided by Merck KGaA and GlaxoSmithKline.
: B. Tan received research grants from EMD Serono Research & Development Institute, Inc., Billerica, MA, USA; an affiliate of Merck KGaA, Darmstadt, Germany. A. Khattak has consulted for Merck Healthcare Pty. Ltd., Australia; an affiliate of Merck KGaA, Darmstadt, Germany; received research grants from Merck Sharp & Dohme; and reports honoraria from Bayer, Bristol Myers Squibb, Merck Sharp & Dohme, Pfizer, Merck Healthcare Pty. Ltd., and Novartis. E. Felip has consulted for AbbVie, AstraZeneca, Blueprint Medicines, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Guardant Health, Janssen, Merck KGaA, Darmstadt, Germany, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Samsung, Takeda, and GlaxoSmithKline; has received research grants from Fundación Merck Salud; reports honoraria from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, prIME Oncology, Medscape, and touchIME; and is an independent member of the Grifols board. K. Kelly has consulted for AbbVie, AstraZeneca, Bristol Myers Squibb, EMD Serono Research & Development Institute, Inc., Billerica, MA, USA; an affiliate of Merck KGaA, Darmstadt, Germany, Eli Lilly, Inviata, Novartis, Regeneron, and Takeda; received research grants and other research support from AbbVie, Bristol Myers Squibb, Celgene, EMD Serono Research & Development Institute, Inc., Five Prime, Genentech, Eli Lilly, Lycera, Merck, Novartis, Regeneron, Tizona, and Transgene; reports honoraria from Merck; and reports royalties from UpToDate. P. Rich is an employee of Cancer Treatment Centers of America. D. Wang declares no competing interests. C. Helwig is an employee of and has ownership interest in Merck KGaA, Darmstadt, Germany. I. Dussault is an employee of EMD Serono Research & Development Institute, Inc., Billerica, MA, USA; an affiliate of Merck KGaA, Darmstadt, Germany; and has ownership interest in EMD Serono Research & Development Institute, Inc., and Amgen. L.S. Ojalvo is an employee of and reports intellectual property interests with EMD Serono Research & Development Institute, Inc., Billerica, MA, USA; an affiliate of Merck KGaA, Darmstadt, Germany. N. Isambert has consulted for Ipsen and Transgene.
: The protocol for this study was approved by all relevant regulatory authorities and ethics committees at participating institutions, and the study was conducted in accordance with the International Conference on Harmonisation Topic E6 Good Clinical Practice and the Declaration of Helsinki. Each patient provided written informed consent before study enrollment.
: All authors gave final approval of the version to be published.
: Not applicable.
: CH, ID, and LSO contributed to study conception and design; BT, AK, EF, KK, PR, DW, and NI contributed to data acquisition. All authors contributed to data interpretation and drafting of the manuscript. All authors reviewed and approved the final manuscript and approved the final manuscript for publication.