Competing interests
JJL: DSMB (Abbvie and Immutep); scientific advisory board: ([no stock] 7 Hills, Fstar, Inzen, RefleXion, Xilio [stock] Actym, Alphamab Oncology, Arch Oncology, Kanaph, Mavu, Onc.AI, Pyxis, and Tempest); consultancy fees (Abbvie, Alnylam, Avillion, Bayer, Bristol-Myers Squibb, Checkmate, Codiak, Crown, Day One, Eisai, EMD Serono, Endeavor, Flame, Genentech, Gilead, HotSpot, Kadmon, KSQ, Janssen, Ikena, Immunocore, Incyte, Macrogenics, Merck, Mersana, Nektar, Novartis, Pfizer, Regeneron, Ribon, Rubius, Servier, Silicon, Synlogic, Synthekine, TRex, Werewolf, and Xencor); research support to institution (AbbVie, Agios, Astellas, Astrazeneca, Bristol-Myers Squibb, Corvus, Day One, EMD Serono, Fstar, Genmab, Ikena, Immatics, Incyte, Kadmon, KAHR, Macrogenics, Merck, Moderna, Nektar, Next Cure, Numab, Pfizer, Replimmune, Rubius, Scholar Rock, Synlogic, Takeda, Trishula, Tizona, and Xencor); provisional patents (Serial #15/612,657 [Cancer Immunotherapy], PCT/US18/36052 [Microbiome Biomarkers for Anti-PD-1/PD-L1 Responsiveness: Diagnostic, Prognostic and Therapeutic Uses Thereof]). MF: Speaker Bureau (Amgen and Guardant360); advisory board (Array BioPharma, Bayer, BGB Group/GlaxoSmithKline, Mirati Therapeutics, Inc., Pfizer, Seattle Genetics, Taiho, and Zhuhai Yufan Biotechnology Co.); consulting/steering committee for study (Incyte Corp.); editorial board (Mirati Therapeutics, Inc.); research support to institution (Amgen, AstraZeneca, Novartis, Verastem, and Bristol Myers Squibb). CS has nothing to disclose. EGC: research funding (Boehringer-Ingelheim, BMS, Celgene, Clovis, Incyte, Lilly, MacroGenics, Roche, Stemline, Halozyme, Merck, Fibrogen, Rafael, Corcept, Lonza); scientific advisory boards/consultancy (AstraZeneca, Celgene, Eisai, Legend, Sobi, Pfizer, Noxxon, BioNTech, Ipsen, Bayer, Cardiff, Novartis, Merck). JB: research funding to institution (Gilead, Genentech/Roche, BMS, Five Prime, Lilly, 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, 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 Oncology, Unum Therapeutics, Vyriad, Harpoon, ADC, Amgen, Pfizer, Millennium, Imclone, Acerta Pharma, Rgenix, Bellicum, Gossamer Bio, Arcus Bio, Seattle Genetics, TempestTx, Shattuck Labs, Synthorx, Inc., Revolution Medicines, Inc., Bicycle Therapeutics, Zymeworks, Relay Therapeutics, Scholar Rock, NGM Biopharma, Stemcentrx, Beigene, CALGB, Cyteir Therapeutics, Foundation Bio, Innate Pharma, Morphotex, OncXerna, NuMab, AtlasMedx, Treadwell Therapeutics, IGM Biosciences, Mabspace, Hutchinson MediPharma, REPARE Therapeutics, NeoImmune Tech, Regeneron, PureTech Health); consulting/advisory role (Gilead, Genentech/Roche, BMS, Five Prime, Lilly, Merck, MedImmune, Celgene, Taiho, Macrogenics, GSK, Novartis, OncoMed, LEAP, TG Therapeutics, AstraZeneca, BI, Daiichi Sankyo, Bayer, Incyte, Apexigen, Array, Sanofi. ARMO, Ipsen, Merrimack, Oncogenex, FORMA, Arch Oncology, Prelude Therapeutics, Phoenix Bio, Cyteir, Molecular Partners, Innate, Torque, Tizona, Janssen, Tolero, Amgen, Seattle Genetics, Moderna Therapeutics, Tanabe Research Laboratories, Beigene, Continuum Clinical, Agios, Bicycle Therapeutics, Relay Therapeutics, Evelo, Pfizer, Samsung Bioepios, Fusion Therapeutics); food/beverage/travel accommodations (Gilead, Genentech/Roche, BMS, Lilly, Merck, MedImmune, Celgene, Taiho, Novartis, OncoMed, BI, ARMO, Ipsen, Oncogenex, FORMA). RKr: advisory board/speaking role (Incyte). RKu: research funding (Biological Dynamics, Boehringer Ingelheim, Debiopharm, Foundation Medicine, Genentech, Grifols, Guardant, Incyte, Konica Minolta, Medimmune, Merck Serono, Omniseq, Pfizer, Sequenom, Takeda, and TopAlliance); consulting fees and/or speaker fees and/or advisory board (Actuate Therapeutics, AstraZeneca, Bicara Therapeutics, Biological Dynamics, EISAI, EOM Pharmaceuticals, Iylon, Merck, NeoGenomics, Neomed, Pfizer, Prosperdtx, Roche, TD2/Volastra, Turning Point Therapeutics, and X-Biotech); equity interest (CureMatch Inc., CureMetrix, and IDbyDNA); board membership (CureMatch and CureMetrix); co-founder (CureMatch). SPB: research funding to conduct clinical trials (Nucana PLC, Sierra Oncology, Astex, Incyte, Tesaro, Redx, MSD, Roche, UCB); consulting (Ellipses, Amphista); director (RNA Guardian ltd). IB: research funding (Incyte, Merck Sharp & Dohme, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Gliknik, ISA Pharmaceuticals, Janssen Oncology, Kura, Merck Serono, Nanobiotics, Novartis, Northern Biologics, Orion Pharma, Regeneron, Pfizer, Seattle Genetics, Shattuck Labs, VCN Biosciences); institutional grants (Cellex Foundation, La Caixa Foundation, Banco Bilbao Vizcaya Argentaria Foundation); consulting fees (Achilles Therapeutics, Bristol Myers Squibb, Cancer Expert Now, eTheRNA Immunotherapies, Merck Serono, Merck Sharp & Dohme, Rakuten pharma); honoraria (Bristol Myers Squibb, Merck Serono, Merck Sharp & Dohme); meeting/travel accommodations (Merck Sharp & Dohme, Merck Serono). LWG: consulting or advisory role (Lilly, Eisai, Bayer/Onyx, Newlink Genetics, QED, AstraZeneca, Incyte, Genentech, and Merck); research funding (Astellas Pharma, Pfizer, Onyx, Sun Pharma, Lilly, Bristol-Myers Squibb, Agios, ArQule, H3 Biomedicine, Incyte, Leap Therapeutics, ASLAN Pharmaceuticals, BeiGene, and Basilea). KOH, RG, MS, and FZ are employees and stockholders of Incyte Corporation. AN: research funding (NCI, EMD Serono, MedImmune, Healios Onc. Nutrition, Atterocor/Millendo, Amplimmune, ARMO BioSciences, Karyopharm Therapeutics, Incyte, Novartis, Regeneron, Merck, Bristol-Myers Squibb, Pfizer, CytomX Therapeutics, Neon Therapeutics, Calithera Biosciences, TopAlliance Biosciences, Eli Lilly, Kymab, PsiOxus, Arcus Biosciences, NeoImmuneTech, ImmuneOncia, and Surface Oncology); advisory board (CytomX Therapeutics, Novartis, Genome & Company, OncoSec KEYNOTE-695, Kymab, and STCube Pharmaceuticals); travel/accommodation expenses (ARMO BioSciences); research funding to spouse (Immune Deficiency Foundation, Jeffery Modell Foundation and chao physician-scientist, and Baxalta); advisory board participation by spouse (Takeda, CSL, Behring, and Horizon Pharma).
Ethics approval and consent to participate
The study protocol was approved by the independent ethics committee/institutional review board at each institution (BSD/IRB, The University of Chicago Biological Sciences Division/University of Chicago Medical Center; Vanderbilt University Institutional Review Board; Western Institutional Review Board; UC San Diego Human Research Protections Program; The University of Texas MD Anderson Cancer Center Institutional Review Board Center; London – Surrey Boarders Research Ethics Committee; and CEIm de la Comunidad Foral de Navarra Departamento de Salud. Pabellón de Docencia). All patients provided written informed consent before initiating treatment.
Consent for publication
Not applicable.