Gutierrez, Martin http://orcid.org/0000-0003-3156-3159
Lam, Wei-Sen
Hellmann, Matthew D.
Gubens, Matthew A.
Aggarwal, Charu
Tan, Daniel Shao Weng http://orcid.org/0000-0002-6514-6786
Felip, Enriqueta
Chiu, Joanne W. Y. http://orcid.org/0000-0002-8320-3166
Lee, Jong-Seok
Yang, James Chih-Hsin
Garon, Edward B. http://orcid.org/0000-0001-7077-8801
Finocchiaro, Giovanna
Ahn, Myung-Ju
Luft, Alexander
Landers, Gregory A.
Basso, Andrea
Ma, Hua
Kobie, Julie
Palcza, John
Cristescu, Razvan http://orcid.org/0000-0002-9978-0339
Fong, Lawrence
Snyder, Alexandra http://orcid.org/0000-0002-2606-3523
Yuan, Jianda
Herbst, Roy S. http://orcid.org/0000-0003-2535-5847
Funding for this research was provided by:
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA
Article History
Received: 31 October 2022
Accepted: 3 May 2023
First Online: 10 July 2023
Competing interests
: M.G. reports a speaker role with Guardant Health; a consultant role with Cellularity; and stocks/shares with COTA. M.D.H. reports grants from Bristol Myers Squibb; personal fees from Achilles, Adagene, Adicet, Arcus, AstraZeneca, Blueprint, Bristol Myers Squibb, DaVolterra, Eli Lilly, Genentech/Roche, Genzyme/Sanofi, Janssen, Immunai, Instil Bio, Mana Therapeutics, Merck, Mirati, Natera, Pact Pharma, Shattuck Labs and Regeneron; and equity options from Factorial, Immunai, Shattuck Labs, Arcus and Avail Bio. A patent filed by Memorial Sloan Kettering related to the use of tumor mutational burden to predict response to immunotherapy (PCT/US2015/062208) is pending and licensed by Personal Genome Diagnostics. Subsequent to the completion of this work, M.D.H. began as an employee (and equity holder) at AstraZeneca. M.A.G. reports funding to institution from Amgen, Celgene, Johnson & Johnson, Merck, Novartis, Oncomed and Trizill and personal financial interests in AstraZeneca, Bristol Myers Squibb, Genentech/Roche, Guardant Health, iTeos, Surface and Genzyme/Sanofi. C.A. reports consulting or advisory roles with Genentech, Eli Lilly, Celgene, Merck, AstraZeneca, Blueprint Genetics, Shionogi, Daiichi Sankyo, Regeneron, Sanofi, Eisai, Beigene, Turning Point, Pfizer, Janssen and Boehringer Ingelheim and research funding to institution from Genentech, Roche, Incyte, Macrogenics, Merck Sharp & Dohme and AstraZeneca/MedImmune. D.S.W.T. reports consultancy with Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, DKSH, GlaxoSmithKline, Merck, Novartis, Pfizer, Roche and Takeda and grant/research support from ACM Biolabs, Amgen, AstraZeneca and Pfizer. E.F. reports roles on advisory boards for Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, F. Hoffmann-La Roche, GlaxoSmithKline, Janssen, Merck Sharp & Dohme, Merck Serono, Novartis, Peptomyc, Pfizer, Sanofi and Takeda; speaker roles with Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, F. Hoffman-La Roche, Janssen, Medscape, Merck Sharp & Dohme, Peervoice, Pfizer, Medical Trends, Merck Serono, Sanofi, Takeda and TouchOncology; research funding from Merck KGaA and Fundacion Merck Salud; and independent fees from Grifols. J.C.-H.Y. reports personal fees and other from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, Merck KGaA, Merck Sharp & Dohme, Novartis, Ono Pharmaceuticals, Pfizer, Roche/Genentech, Takeda Oncology, Yuhan Pharmaceuticals, Johnson & Johnson, Puma Technology, Gilead and GlaxoSmithKline. E.B.G. reports consultant and/or advisor roles for ABL-Bio, AstraZeneca, AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Dracen Pharmaceuticals, EMD Serono, Eisai, Eli Lilly, Gilead, GlaxoSmithKline, Merck, Natera, Novartis, Personalis, Regeneron, Sanofi, Shionogi and Xilio and grand/research support from ABL-Bio, AstraZeneca, Bristol Myers Squibb, Dynavax Technologies, Eli Lilly, EMD Serono, Genentech, Iovance Biotherapeutics, Merck, Mirati Therapeutics, Neon and Novartis. A.B., J.K., H.M., J.P., R.C. and J.Y. report employment and stock ownership at Merck Sharp & Dohme. H.M. and A.S. were previously employed by and report stock ownership at Merck Sharp & Dohme. L.F. has received research support from Roche/Genentech, AbbVie, Bavarian Nordic, Bristol Myers Squibb, Dendreon, Janssen, Merck and Partner Therapeutics and served on the scientific advisory boards of Actym, Alector, AstraZeneca, Atreca, Bioalta, Bolt, Bristol Myers Squibb, Daiichi Sankyo, Immunogenesis, Innovent, Merck, Merck KGaA, Nutcracker, RAPT, Scribe, Senti, Soteria, Sutro and Roche/Genentech. R.S.H. reports consulting roles with AbbVie Pharmaceuticals, ARMO Biosciences, AstraZeneca, Biodesix, Bolt Biotherapeutics, Bristol Myers Squibb, Cybrexa Therapeutics, eFFECTOR Therapeutics, Eli Lilly, EMD Serono, Genentech/Roche, Genmab, Halozyme Therapeutics, Heat Biologics, I-Mab Biopharma, Immunocore, Infinity Pharmaceuticals, Loxo Oncology, Merck, Mirati Therapeutics, Nektar, Neon Therapeutics, NextCure, Novartis, Oncternal Therapeutics, Pfizer, Sanofi, Seattle Genetics, Shire, Spectrum Pharmaceuticals, STCube Pharmaceuticals, Symphogen, Takeda, Tesaro, Tocagen and WindMIL Therapeutics; advisory board roles with AstraZeneca, Bolt Biotherapeutics, Cybrexa Therapeutics, EMD Serono, I-Mab Biopharma, Immunocore, Infinity Pharmaceuticals, Neon Therapeutics, Novartis and STCube Pharmaceuticals; research support from AstraZeneca, Eli Lilly, Genentech/Roche and Merck; and non-executive board membership for Junshi Pharmaceuticals and Immunocore. W.-S.L., J.W.Y.C., J.-S.L., G.F., M.-J.A., A.L. and G.A.L. have no competing interests to report. Funding for this research was provided by Merck Sharp & Dohme. The funder participated in study design, data analysis and interpretation and manuscript writing and maintained the study database. All authors had full access to the data and had final responsibility for the decision to submit the manuscript for publication.