Acknowledgments
We thank the patients and their families and caregivers for participating in the study. We also thank Mohammed Farooqui for study oversight, Seth Thompson for statistical support and Victoria Fox, Kathryn Fogarty, and Laura Sharon for study team support (Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA). Medical writing and/or editorial assistance was provided by Doyel Mitra, PhD, CMPP, and Matthew Grzywacz, PhD, of the ApotheCom pembrolizumab team (Yardley, PA, USA). This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Authorship
Contribution: R.C., P.A., A.B., and C.H.M. conceived, designed, and planned the study. P.L.Z., R.C., P.A., N.A.J., J.R., V.R., D.M., T.P.V., A.T., B.v.T., and A.B. acquired the data. R.C., B.v.T., M.A.S., J.L., A.B., and C.H.M analyzed the data. P.L.Z., R.C., P.A., P.B., J.R., V.R., D.M., T.P.V., B.v.T., M.A.S., J.L., A.N., A.B., and C.H.M. interpreted the results. A.B. and C.H.M. drafted the manuscript. All authors had full access to all the data in the study, contributed to reviewing and revising the manuscript, and had final responsibility for the decision to submit for publication.
Disclosure statement
P.L.Z. reports membership of a speakers bureau with Verastem, Celltrion, Gilead, Janssen-Cilag, Bristol-Myers Squibb, Servier, Merck, Immune Design, Celgene, Portola, Roche, Eusapharma, Kyowa Kirin, is a consultant for Verastem, Merck, Eusapharma, Sanofi, and is a member of an advisory board for Verastem, Celltrion, Gilead, Janssen-Cilag, Bristol-Myers Squibb, Servier, Sandoz, Merck, Immune Design, Celgene, Portola, Roche, Eusapharma, Kyowa Kirin. A.T. has nothing to disclose. R.C. reports employment/leadership position/advisory role at Seattle Genetics, Pharmacyclics, Merck, Genentech Inc., Millennium Pharmaceuticals, Inc.; honoraria from Seattle Genetics; research funding from Merck, Bristol-Myers Squibb, Seattle Genetics, Millennium Pharmaceuticals, Inc., Pharmacyclics. P.A. reports consultancy for Merck, Bristol-Myers Squibb, Pfizer, Affimed, Adaptive, Infinity, ADC Therapeutics, Celgene, Morphosys, Daiichi Sankyo, Miltenyi, research funding (inst) from Merck, Bristol Myers Squibb, Affimed, Adaptive, Roche, Tensha, Otsuka, Sigma Tau, Genentech, IGM, Kite (pending) and honoraria from Merck and Bristol Myers Squibb. N.A.J. reports employment/leadership position/advisory role at Roche, AbbVie Inc., Lundbeck; honoraria from Roche, AbbVie Inc., Lundbeck, Seattle Genetics; research funding from Roche, AbbVie Inc., Lundbeck; travel fees, gifts, and others from Roche, Lundbeck. P.B. reports honoraria from Takeda France, Bristol-Myers Squibb; consulting or advisory role at Takeda France; research funding from Millennium Takeda. J.R. reports employment/leadership position/advisory role at Takeda Pharmaceutical Company, Seattle Genetics, Novartis; stock ownership or options from GlaxoSmithKline, AstraZeneca; research funding from Takeda Pharmaceutical Company. V.R. reports membership of scientific advisory boards for Epizyme, Servier, Nanostring, Gilead, Pharmamar, Bristol-Myers Squibb, Merck, Incyte, Roche, Infinity, received research funding from Epizyme and ArgenX and is consultant for Servier. D.M. reports honoraria from Roche Holding AG, Merck, Bristol-Myers Squibb, Takeda Pharmaceutical Company. T.P.V. reports employment/leadership position/advisory role at Roche, Takeda Pharmaceutical Company, Genesis Pharmaceutical, Inc., Novartis, Bristol-Myers Squibb, Servier; honoraria from Roche, Takeda Pharmaceutical Company, Genesis Pharmaceutical, Inc., Novartis, Bristol-Myers Squibb, Merck, Winmedica; travel fees, gifts, and others from Roche, Takeda Pharmaceutical Company, Genesis Pharmaceutical, Inc. B.v.T. reports grants, personal fees, and non-financial support from Merck, Novartis, and Takeda. M.A.S. reports employment/leadership position/advisory role at AstraZeneca, Bristol-Myers Squibb, Merck, Gilead Sciences, Inc., Takeda Pharmaceutical Company; honoraria from AstraZeneca, Bristol-Myers Squibb, Merck, Gilead Sciences, Inc., Takeda Pharmaceutical Company; research funding from Bristol-Myers Squibb, Bayer. J.L. and A.N. report employment at Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. A.B. reports employment at Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, stock ownership at Merck & Co., Inc., Kenilworth, NJ, USA, and Amgen. C.H.M. reports employment/leadership position/advisory role at Celgene, Genentech Inc, Merck, Seattle Genetics; research funding from Pharmacyclics, Genentech Inc, Merck, Seattle Genetics.
Data sharing statement
Merck & Co., Inc.’s data sharing policy, including restrictions, is available at http://engagezone.msd.com/ds_documentation.php. Requests for access to the clinical study data can be submitted through the EngageZone site or via email to [email protected].