Hecht, J. Randolph http://orcid.org/0000-0003-2277-4157
Papadopoulos, Kyriakos P.
Falchook, Gerald S.
Patel, Manish R.
Infante, Jeffrey R.
Aljumaily, Raid
Wong, Deborah J.
Autio, Karen A.
Wainberg, Zev A.
Bauer, Todd M.
Javle, Milind
Pant, Shubham
Bendell, Johanna
Hung, Annie
Ratti, Navneet
VanVlasselaer, Peter
Verma, Rakesh
Leveque, Joseph
Rao, Sujata
Oft, Martin
Naing, Aung
Funding for this research was provided by:
Eli Lilly and Company (none)
Article History
Received: 13 August 2020
Accepted: 4 September 2020
First Online: 10 September 2020
Compliance with ethical standards
:
: <b>J. Randolph Hecht</b> declares honoraria from ARMO BioSciences a wholly owned subsidiary of Eli Lilly and Company, AstraZeneca, Bristol-Myers Squibb, Gritstone, Halozyme, Ipsen, Merck, Roche; research funding from Abbvie, Advaxis, Amgen, ARMO BioSciences a wholly owned subsidiary of Eli Lilly and Company, Astellas Pharma, Forty Seven, Halozyme, Immunomedics, Eli Lilly and Company, Merck, Novartis; and travel accommodations and expenses from Advaxis, Eli Lilly and Company. <b>Kyriakos P. Papadopoulos</b> declares research funding from Abbvie, Amgen, ArQule, ARMO Biosciences a wholly owned subsidiary of Eli Lilly and Company, ADC Therapeutics, Anheart, 3D Medicines, Basilia, Bayer, Calithera Biosciences, Daiichi Sankyo, EMD Serono, F-star, Incyte, Jounce Therapeutics, Linnaeus, Mabspace Biosciences, Merck, Mirati Therapeutics, MedImmune, Mersana, Peloton Therapeutics, Regeneron, Syros Pharmaceuticals and Tempest Therapeutics; advisory board fees from Arqule, Basilia, Bayer. <b>Gerald S. Falchook</b> declares consulting or advisory role with EMD Serono, Fujifilm; speakers’ bureau with Total Health Conferencing, Rocky Mountain Oncology Society; research funding from 3-V Biosciences, Abbisko, Abbvie, ADC Therapeutics, Aileron Therapeutics, American Society of Clinical Oncology, Amgen, ARMO BioSciences a wholly owned subsidiary of Eli Lilly and Company, AstraZeneca, BeiGene, Bioatla, Bioinvent, Biothera, Bicycle, Celgene, Celldex, Ciclomed, Curegenix, Curis, Cyteir, Daiichi, DelMar Pharmaceuticals, eFFECTOR Therapeutics, Eli Lilly and Company, EMD Serono, Epizyme, Exelixis, Fujifilm, Genmab, GlaxoSmithKline, Hutchison MediPharma, Ignyta, Incyte, Jacobio, Jounce Therapeutics, Koltan Pharmaceuticals, Loxo, MedImmune, Merck, Millenium, miRNA Therapeutics, National Institutes of Health, Novartis, OncoMed, Oncorus, Oncothyreon, Poseida, Precision Oncology, Prelude, Regeneron, Rgenix, Ribon Therapeutics, Sapience, Strategia Therapeutics, Synthorx, Syndax, Taiho Pharmaceutical, Takeda, Tarveda Therapeutics, Tesaro, Tocagen, Turning Point Therapeutics, U.T. MD Anderson Cancer Center, Vegenics, Xencor; patents royalties and other intellectual property with Wolters Kluwer; and travel accommodations and expenses from Bristol-Myers Squibb, EMD Serono, Fujifilm, Millenium, Sarah Cannon Research Institute. <b>Manish R. Patel</b> declares honoraria from Bayer, Genentech, Janssen Oncology, Pfizer, Pharmacyclics; consulting of advisory role with Pfizer/EMD Serono, Pharmacyclics/Janssen; speakers’ bureau with Celgene, Exelixis, Genentech/Roche, Taiho Pharmaceutical; research funding from Acerta Pharma, ADC Therapeutics, Agenus, Aileron Therapeutics, AstraZeneca, Bicycle Therapeutics, BioNTech AG, Boehringer Ingelheim, Calithera Biosciences, Celgene, Checkpoint Therapeutics, CicloMed, Clovis Oncology, Curis, Cyteir Therapeutics, Daiichi Sankyo, eFFECTOR Therapeutics, EMD Serono, Evelo Therapeutics, FORMA Therapeutics, Genentech/Roche, Gilead Sciences, GlaxoSmithKline, H3 Biomedicine, Hengrui Therapeutics, Hutchison MediPharma, Ignyta, Incyte, Jacobio, Janssen, Jounce Therapeutics, Klus Pharma, Kymab, Eli Lilly and Company, Loxo, LSK Biopartners, Lycera, Macrogenics, Merck, Millenium, Mirati Therapeutics, Moderna Therapeutics, Pfizer, Phoenix Molecular Designs, Placon, Portola Pharmaceuticals, Prelude Therapeutics, Puget Sound Biotherapeutics, QiLu Pharmaceuticals, Stemline Therapeutics, Syndax, Synthorx, Taiho Pharmaceutical, Takeda, Tesaro, TopAlliance BioSciences Inc., Vedanta Biosciences, Verastem, Vigeo, Xencor. <b>Jeffrey R. Infante</b> declares employment with Janssen Research & Development with stock and other ownership interests with Johnson & Johnson. <b>Raid Aljumaily</b> declares consulting or advisory role with AstraZeneca, Regeneron; research funding from Abbvie, Alliance Foundation Trials LLC, Array BioPharma, AstraZeneca, Baxalta, Boehringer Ingelheim, Boston Biomedical, Bristol-Myers Squibb, Checkpoint Therapeutics Inc., EMD Serono, F. Hoffman-La Roche AG, G1 Therapeutics, Genentech, GlaxoSmithKline, Huntsman Cancer Institute, Eli Lilly and Company, MedImmune LLC, Merck Co, Novartis, Peloton Therapeutics Inc., Pfizer, Regeneron, Syneos Health, Tesaro. <b>Karen A. Autio</b> declares research funding from Amgen, ARMO BioSciences a wholly owned subsidiary of Eli Lilly and Company, AstraZeneca, CytomX Therapeutics, GlaxoSmithKline, Merck, Pfizer, Tizona Therapeutics Inc. <b>Zev A. Wainberg</b> declares consulting or advisory role with AstraZeneca, Bayer, Eli Lilly and Company, Merck, Novartis; research funding from Novartis, Ipsen, Plexxikon. <b>Todd M. Bauer</b> declares research funding from Daiichi Sankyo, Medpacto, Incyte, Mirati Therapeutics, MedImmune, Abbvie, AstraZeneca, MabVax, Stemline Therapeutics, Merck, Eli Lilly and Company, GlaxoSmithKline, Novartis, Genentech, Deciphera, Merrimack, Immunogen, Millennium, Phosplatin Therapeutics, Calithera Biosciences, Kolltan Pharmaceuticals, Principa Biopharma, Peleton, Immunocore, Roche, Aileron Therapeutics, Bristol-Myers Squibb, Amgen, Onyx, Sanofi, Boehringer-Ingelheim, Astellas Pharma, Five Prime Therapeutics, Jacobio, Top Alliance BioScience, Janssen, Clovis Oncology, Takeda, Karyopharm Therapeutics, Foundation Medicine, ARMO Biosciences a wholly owned subsidiary of Eli Lilly and Company, Leap Therapeutics; grants and non-financial support and consulting services and/or personal fees from Ignyta, Moderna Therapeutics, Pfizer, Loxo, Bayer, Guardant Health; and personal fees from Exelesis. <b>Milind Javle</b> declares consulting or advisory role with Incyte, Mundi, Oncosil, QED; other relationship with Bayer, BeiGene, Incyte, Merck, Merck Serono, Novartis, Pieris Pharmaceuticals, QED Therapeutics, Rafael Pharmaceuticals, Seattle Genetics. <b>Shubham Pant</b> declares honoraria from 4D Pharma; consulting or advisory role with TYME, Xencor, Ipsen; and research funding from ArQule, Bristol-Myers Squibb, Five Prime Therapeutics, GlaxoSmithKline, Ipsen, Eli Lilly and Company, Mirati Therapeutics, Novartis, Onco Response, RedHill BioPharma, Rgenix, Sanofi/Aventis, Xencor. <b>Johanna Bendell</b> declares research funding Gilead, Genentech/Roche, Bristol-Myers Squibb, Five Prime, Eli Lilly and Company, Merck, MedImmune, Celgene, EMD Serono, Taiho, Macrogenics, GSK, Novartis, OncoMed, LEAP, TG Therapeutics, AstraZeneca, BI, Daiichi Sankyo, Bayer, Incyte, Apexigen, Koltan, SynDevRex, Forty Seven, Abbvie, Array, Onyx, Sanofi, Takeda, Eisai, Celldex, Agios, Cytomx, Nektar, ARMO BioSciences a wholly owned subsidiary of Eli Lilly and Company, Boston Biomedical, Ipsen, Merrimack, Tarveda, Tyrogenex, Oncogenex, Marshall Edwards, Pieris, Mersana, Calithera, Blueprint, Evelo, FORMA, Merus, Jacobio, Effector, Novocare, Arrys, Tracon, Sierra, Innate, Arch Oncology, Prelude Therapeutics, Unum Therapeutics, Vyriad, Harpoon, ADC, Amgen, Pfizer, Millenium, Imclone, Acerta Pharma, Rgenix, Bellicum, Gossamer Bio, Arcus Bio, Seattle Genetics, Tempest Tx, Shattuck Labs, Synthorx Inc., Revolution Medicines Inc., Bicycle Therapeutics, Zymeworks, Relay Therapeutics, Atlas Medx, Scholar Rock, NGM Biopharma; consulting services with Gilead, Genentech/Roche, Bristol-Myers Squibb, Five Prime, Eli Lilly and Company, Merck, MedImmune, Celgene, Taiho, Macrogenics, GSK, Novartis, OncoMed, LEAP, TG Therapeutics, AstraZeneca, BI, Daiichi Sankyo, Bayer, Incyte, Apexigen, Ipsen, Merrimack, Oncogenex, Evelo, FORMA, Innate, Arch Oncology, Prelude Therapeutics, Bicycle Therapeutics, Relay Therapeutics, Phoenix Bio, Cyteir, Molecular Partners, Torque, Tizona, Janssen, Tolero, TD2 (Translational Drug Development), Moderna Therapeutics, Tanabe Research Laboratories, Beigene, Continuum Clinical, Amgen, Evelo, Piper Biotech, Samsung Bioepios, ARMO BioSciences a wholly owned subsidiary of Eli Lilly and Company, Agios, Sanofi, Array. <b>Joseph Leveque</b> declares previous employment with stock holdings from ARMO BioSciences a wholly owned subsidiary of Eli Lilly and Company and Synthorx and current employment with stock holdings from Mirati Therapeutics (serving as CMO). <b>Navneet Ratti, Peter VanVlasselaer, Rakesh Verma, and Martin Oft</b> declare former employment with ARMO BioSciences a wholly owned subsidiary of Eli Lilly and Company with stock holdings. <b>Annie Hung and Sujata Rao</b> declare former employment with ARMO BioSciences a wholly owned subsidiary of Eli Lilly and Company and current employment of Eli Lilly and Company with stock holdings. <b>Aung Naing</b> declares consulting or advisory role with CytomX Therapeutics, Novartis, Kymab, Genome; research funding with Amplimmune, ARMO BioSciences a wholly owned subsidiary of Eli Lilly and Company, Atterocor, Bristol-Myers Squibb, Calithera BioSciences, CytomX Therapeutics, EMD Serono, Healios Onc Nutrition, Immune Deficiency Foundation (Spouse), Incyte, Karyopharm Therapeutics, Kymab, Eli Lilly and Company, MedImmune, Merck, NCI, Neon Therapeutics, Novartis, Pfizer, PsiOxus Therapeutics, Regeneron, TopAlliance BioSciences Inc.; travel, accommodations, and expenses from ARMO BioSciences a wholly owned subsidiary of Eli Lilly and Company.
: All procedures performed in the study involving human participants were in accordance with Good Clinical Practice Guidelines (GCP), the US Code of Federal Regulations governing the protection of human patients (21 CFR 50), International Conference on Harmonization (ICH) guidelines, local ethical requirements consistent with the current version of the Declaration of Helsinki, and the Institutional Review Board or Independent Ethics Committees (IEC; 21 CFR 56).
: Informed consent was obtained from all individual participants included in the study.