{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T20:45:22Z","timestamp":1793306722066,"version":"4.5.0"},"reference-count":37,"publisher":"Springer Science and Business Media LLC","issue":"2","license":[{"start":{"date-parts":[[2023,2,14]],"date-time":"2023-02-14T00:00:00Z","timestamp":1676332800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2023,2,14]],"date-time":"2023-02-14T00:00:00Z","timestamp":1676332800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"funder":[{"DOI":"10.13039\/100017655","name":"Incyte","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100017655","id-type":"DOI","asserted-by":"publisher"}]},{"name":"NIH \/ NCI Cancer Center"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Targ Oncol"],"published-print":{"date-parts":[[2023,3]]},"DOI":"10.1007\/s11523-023-00948-8","type":"journal-article","created":{"date-parts":[[2023,2,17]],"date-time":"2023-02-17T06:32:44Z","timestamp":1676615564000},"page":"181-193","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["First-in-Human Study of INCB062079, a Fibroblast Growth Factor Receptor 4 Inhibitor, in Patients with Advanced Solid Tumors"],"prefix":"10.1007","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7029-4310","authenticated-orcid":false,"given":"James J.","family":"Harding","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christiane","family":"Jungels","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Pascal","family":"Machiels","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David C.","family":"Smith","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chris","family":"Walker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tao","family":"Ji","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ping","family":"Jiang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xin","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ekaterine","family":"Asatiani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Van Cutsem","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ghassan K.","family":"Abou-Alfa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,2,14]]},"reference":[{"key":"948_CR1","doi-asserted-by":"publisher","first-page":"247ra100","DOI":"10.1126\/scitranslmed.3009098","volume":"6","author":"J Luo","year":"2014","unstructured":"Luo J, Ko B, Elliott M, Zhou M, Lindhout DA, Phung V, et al. A nontumorigenic variant of FGF19 treats cholestatic liver diseases. Sci Transl Med. 2014;6:247ra100. https:\/\/doi.org\/10.1126\/scitranslmed.3009098.","journal-title":"Sci Transl Med."},{"key":"948_CR2","doi-asserted-by":"publisher","first-page":"217","DOI":"10.1016\/j.cmet.2005.09.001","volume":"2","author":"T Inagaki","year":"2005","unstructured":"Inagaki T, Choi M, Moschetta A, Peng L, Cummins CL, McDonald JG, et al. Fibroblast growth factor 15 functions as an enterohepatic signal to regulate bile acid homeostasis. Cell Metab. 2005;2:217\u201325. https:\/\/doi.org\/10.1016\/j.cmet.2005.09.001.","journal-title":"Cell Metab"},{"key":"948_CR3","doi-asserted-by":"publisher","first-page":"530","DOI":"10.1111\/j.1365-2796.2006.01731.x","volume":"260","author":"T Lundasen","year":"2006","unstructured":"Lundasen T, Galman C, Angelin B, Rudling M. Circulating intestinal fibroblast growth factor 19 has a pronounced diurnal variation and modulates hepatic bile acid synthesis in man. J Intern Med. 2006;260:530\u20136. https:\/\/doi.org\/10.1111\/j.1365-2796.2006.01731.x.","journal-title":"J Intern Med"},{"key":"948_CR4","doi-asserted-by":"publisher","first-page":"1581","DOI":"10.1101\/gad.1083503","volume":"17","author":"JA Holt","year":"2003","unstructured":"Holt JA, Luo G, Billin AN, Bisi J, McNeill YY, Kozarsky KF, et al. Definition of a novel growth factor-dependent signal cascade for the suppression of bile acid biosynthesis. Genes Dev. 2003;17:1581\u201391. https:\/\/doi.org\/10.1101\/gad.1083503.","journal-title":"Genes Dev"},{"key":"948_CR5","doi-asserted-by":"publisher","first-page":"2202","DOI":"10.1172\/JCI23076","volume":"115","author":"S Ito","year":"2005","unstructured":"Ito S, Fujimori T, Furuya A, Satoh J, Nabeshima Y, Nabeshima Y. Impaired negative feedback suppression of bile acid synthesis in mice lacking \u03b2Klotho. J Clin Invest. 2005;115:2202\u20138. https:\/\/doi.org\/10.1172\/JCI23076.","journal-title":"J Clin Invest"},{"key":"948_CR6","doi-asserted-by":"publisher","first-page":"2457","DOI":"10.4155\/fmc-2018-0099","volume":"10","author":"N Prieto-Dominguez","year":"2018","unstructured":"Prieto-Dominguez N, Shull AY, Teng Y. Making way for suppressing the FGF19\/FGFR4 axis in cancer. Future Med Chem. 2018;10:2457\u201370. https:\/\/doi.org\/10.4155\/fmc-2018-0099.","journal-title":"Future Med Chem"},{"key":"948_CR7","doi-asserted-by":"publisher","first-page":"1696","DOI":"10.1158\/2159-8290.CD-19-0555","volume":"9","author":"RD Kim","year":"2019","unstructured":"Kim RD, Sarker D, Meyer T, Yau T, Macarulla T, Park JW, et al. First-in-human phase I study of fisogatinib (BLU-554) validates aberrant FGF19 signaling as a driver event in hepatocellular carcinoma. Cancer Discov. 2019;9:1696\u2013707. https:\/\/doi.org\/10.1158\/2159-8290.CD-19-0555.","journal-title":"Cancer Discov"},{"key":"948_CR8","doi-asserted-by":"publisher","DOI":"10.1016\/j.pharmthera.2020.107590","volume":"214","author":"KM Levine","year":"2020","unstructured":"Levine KM, Ding K, Chen L, Oesterreich S. FGFR4: a promising therapeutic target for breast cancer and other solid tumors. Pharmacol Ther. 2020;214: 107590. https:\/\/doi.org\/10.1016\/j.pharmthera.2020.107590.","journal-title":"Pharmacol Ther"},{"key":"948_CR9","doi-asserted-by":"publisher","first-page":"706","DOI":"10.1002\/hep.26402","volume":"58","author":"K Wang","year":"2013","unstructured":"Wang K, Lim HY, Shi S, Lee J, Deng S, Xie T, et al. Genomic landscape of copy number aberrations enables the identification of oncogenic drivers in hepatocellular carcinoma. Hepatology. 2013;58:706\u201317. https:\/\/doi.org\/10.1002\/hep.26402.","journal-title":"Hepatology"},{"key":"948_CR10","doi-asserted-by":"publisher","first-page":"505","DOI":"10.1038\/ng.3252","volume":"47","author":"K Schulze","year":"2015","unstructured":"Schulze K, Imbeaud S, Letouze E, Alexandrov LB, Calderaro J, Rebouissou S, et al. Exome sequencing of hepatocellular carcinomas identifies new mutational signatures and potential therapeutic targets. Nat Genet. 2015;47:505\u201311. https:\/\/doi.org\/10.1038\/ng.3252.","journal-title":"Nat Genet"},{"key":"948_CR11","doi-asserted-by":"publisher","first-page":"1245","DOI":"10.7150\/jca.12825","volume":"6","author":"S Shi","year":"2015","unstructured":"Shi S, Li X, You B, Shan Y, Cao X, You Y. High expression of FGFR4 enhances tumor growth and metastasis in nasopharyngeal carcinoma. J Cancer. 2015;6:1245\u201354. https:\/\/doi.org\/10.7150\/jca.12825.","journal-title":"J Cancer"},{"key":"948_CR12","doi-asserted-by":"publisher","first-page":"2394","DOI":"10.1038\/s41388-018-0591-7","volume":"38","author":"L Gao","year":"2019","unstructured":"Gao L, Lang L, Zhao X, Shay C, Shull AY, Teng Y. FGF19 amplification reveals an oncogenic dependency upon autocrine FGF19\/FGFR4 signaling in head and neck squamous cell carcinoma. Oncogene. 2019;38:2394\u2013404. https:\/\/doi.org\/10.1038\/s41388-018-0591-7.","journal-title":"Oncogene"},{"key":"948_CR13","doi-asserted-by":"publisher","first-page":"809","DOI":"10.1158\/1078-0432.CCR-12-2736","volume":"19","author":"TM Zaid","year":"2013","unstructured":"Zaid TM, Yeung TL, Thompson MS, Leung CS, Harding T, Co NN, et al. Identification of FGFR4 as a potential therapeutic target for advanced-stage, high-grade serous ovarian cancer. Clin Cancer Res. 2013;19:809\u201320. https:\/\/doi.org\/10.1158\/1078-0432.CCR-12-2736.","journal-title":"Clin Cancer Res"},{"key":"948_CR14","doi-asserted-by":"publisher","first-page":"54","DOI":"10.1016\/j.bbrc.2014.02.050","volume":"446","author":"YF Xu","year":"2014","unstructured":"Xu YF, Yang XQ, Lu XF, Guo S, Liu Y, Iqbal M, et al. Fibroblast growth factor receptor 4 promotes progression and correlates to poor prognosis in cholangiocarcinoma. Biochem Biophys Res Commun. 2014;446:54\u201360. https:\/\/doi.org\/10.1016\/j.bbrc.2014.02.050.","journal-title":"Biochem Biophys Res Commun"},{"key":"948_CR15","doi-asserted-by":"publisher","first-page":"673","DOI":"10.1038\/89044","volume":"7","author":"J Khan","year":"2001","unstructured":"Khan J, Wei JS, Ringner M, Saal LH, Ladanyi M, Westermann F, et al. Classification and diagnostic prediction of cancers using gene expression profiling and artificial neural networks. Nat Med. 2001;7:673\u20139. https:\/\/doi.org\/10.1038\/89044.","journal-title":"Nat Med"},{"key":"948_CR16","doi-asserted-by":"publisher","first-page":"424","DOI":"10.1158\/2159-8290.CD-14-1029","volume":"5","author":"M Hagel","year":"2015","unstructured":"Hagel M, Miduturu C, Sheets M, Rubin N, Weng W, Stransky N, et al. First selective small molecule inhibitor of FGFR4 for the treatment of hepatocellular carcinomas with an activated FGFR4 signaling pathway. Cancer Discov. 2015;5:424\u201337. https:\/\/doi.org\/10.1158\/2159-8290.CD-14-1029.","journal-title":"Cancer Discov"},{"key":"948_CR17","doi-asserted-by":"publisher","first-page":"6999","DOI":"10.1158\/0008-5472.CAN-17-1865","volume":"77","author":"JJ Joshi","year":"2017","unstructured":"Joshi JJ, Coffey H, Corcoran E, Tsai J, Huang CL, Ichikawa K, et al. H3B\u20136527 is a potent and selective inhibitor of FGFR4 in FGF19-driven hepatocellular carcinoma. Cancer Res. 2017;77:6999\u20137013. https:\/\/doi.org\/10.1158\/0008-5472.CAN-17-1865.","journal-title":"Cancer Res"},{"key":"948_CR18","doi-asserted-by":"publisher","first-page":"347","DOI":"10.1016\/j.ccr.2011.01.040","volume":"19","author":"ET Sawey","year":"2011","unstructured":"Sawey ET, Chanrion M, Cai C, Wu G, Zhang J, Zender L, et al. Identification of a therapeutic strategy targeting amplified FGF19 in liver cancer by oncogenomic screening. Cancer Cell. 2011;19:347\u201358. https:\/\/doi.org\/10.1016\/j.ccr.2011.01.040.","journal-title":"Cancer Cell"},{"key":"948_CR19","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0036713","volume":"7","author":"DM French","year":"2012","unstructured":"French DM, Lin BC, Wang M, Adams C, Shek T, Hotzel K, et al. Targeting FGFR4 inhibits hepatocellular carcinoma in preclinical mouse models. PLoS ONE. 2012;7: e36713. https:\/\/doi.org\/10.1371\/journal.pone.0036713.","journal-title":"PLoS ONE"},{"key":"948_CR20","doi-asserted-by":"publisher","first-page":"2100","DOI":"10.1158\/1538-7445.Am2017-2100","volume":"77","author":"PCC Liu","year":"2017","unstructured":"Liu PCC, Lu L, Bowman K, Stubbs MC, Wu L, DiMatteo D, et al. Selective inhibition of FGFR4 by INCB062079 is efficacious in models of FGF19- and FGFR4-dependent cancers [abstract]. Cancer Res. 2017;77:2100. https:\/\/doi.org\/10.1158\/1538-7445.Am2017-2100.","journal-title":"Cancer Res"},{"key":"948_CR21","doi-asserted-by":"publisher","first-page":"1234","DOI":"10.1158\/1538-7445.Am2017-1234","volume":"77","author":"B Ruggeri","year":"2017","unstructured":"Ruggeri B, Stubbs M, Yang Y-O, Juvekar A, Lu L, Condon S, et al. The novel FGFR4-selective inhibitor INCB062079 is efficacious in models of hepatocellular carcinoma harboring FGF19 amplification [abstract]. Cancer Res. 2017;77:1234. https:\/\/doi.org\/10.1158\/1538-7445.Am2017-1234.","journal-title":"Cancer Res"},{"key":"948_CR22","doi-asserted-by":"publisher","first-page":"2194","DOI":"10.1158\/1535-7163.MCT-18-1291","volume":"18","author":"A Weiss","year":"2019","unstructured":"Weiss A, Adler F, Buhles A, Stamm C, Fairhurst RA, Kiffe M, et al. FGF401, a first-in-class highly selective and potent FGFR4 inhibitor for the treatment of FGF19-driven hepatocellular cancer. Mol Cancer Ther. 2019;18:2194\u2013206. https:\/\/doi.org\/10.1158\/1535-7163.MCT-18-1291.","journal-title":"Mol Cancer Ther"},{"key":"948_CR23","unstructured":"US Food and Drug Administration. Estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers. Available at: https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/estimating-maximum-safe-starting-dose-initial-clinical-trials-therapeutics-adult-healthy-volunteers. Accessed 29 Oct 2021."},{"key":"948_CR24","doi-asserted-by":"publisher","first-page":"205","DOI":"10.1007\/s11739-011-0653-0","volume":"8","author":"F Scaldaferri","year":"2013","unstructured":"Scaldaferri F, Pizzoferrato M, Ponziani FR, Gasbarrini G, Gasbarrini A. Use and indications of cholestyramine and bile acid sequestrants. Intern Emerg Med. 2013;8:205\u201310. https:\/\/doi.org\/10.1007\/s11739-011-0653-0.","journal-title":"Intern Emerg Med"},{"key":"948_CR25","doi-asserted-by":"publisher","first-page":"52","DOI":"10.1055\/s-0030-1247132","volume":"30","author":"R Lencioni","year":"2010","unstructured":"Lencioni R, Llovet JM. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis. 2010;30:52\u201360. https:\/\/doi.org\/10.1055\/s-0030-1247132.","journal-title":"Semin Liver Dis"},{"key":"948_CR26","doi-asserted-by":"publisher","first-page":"228","DOI":"10.1016\/j.ejca.2008.10.026","volume":"45","author":"EA Eisenhauer","year":"2009","unstructured":"Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45:228\u201347. https:\/\/doi.org\/10.1016\/j.ejca.2008.10.026.","journal-title":"Eur J Cancer"},{"key":"948_CR27","doi-asserted-by":"publisher","first-page":"1011","DOI":"10.1007\/s00424-013-1364-3","volume":"466","author":"D Jung","year":"2014","unstructured":"Jung D, York JP, Wang L, Yang C, Zhang A, Francis HL, et al. FXR-induced secretion of FGF15\/19 inhibits CYP27 expression in cholangiocytes through p38 kinase pathway. Pflugers Arch. 2014;466:1011\u20139. https:\/\/doi.org\/10.1007\/s00424-013-1364-3.","journal-title":"Pflugers Arch"},{"key":"948_CR28","doi-asserted-by":"publisher","first-page":"1180","DOI":"10.1016\/j.ajpath.2021.04.014","volume":"191","author":"Z Chen","year":"2021","unstructured":"Chen Z, Jiang L, Liang L, Koral K, Zhang Q, Zhao L, et al. The role of fibroblast growth factor 19 in hepatocellular carcinoma. Am J Pathol. 2021;191:1180\u201392. https:\/\/doi.org\/10.1016\/j.ajpath.2021.04.014.","journal-title":"Am J Pathol"},{"key":"948_CR29","doi-asserted-by":"publisher","first-page":"327","DOI":"10.1159\/000371670","volume":"33","author":"SA Kliewer","year":"2015","unstructured":"Kliewer SA, Mangelsdorf DJ. Bile acids as hormones: the FXR-FGF15\/19 pathway. Dig Dis. 2015;33:327\u201331. https:\/\/doi.org\/10.1159\/000371670.","journal-title":"Dig Dis"},{"key":"948_CR30","doi-asserted-by":"publisher","first-page":"517","DOI":"10.1016\/s1097-2765(00)00051-4","volume":"6","author":"B Goodwin","year":"2000","unstructured":"Goodwin B, Jones SA, Price RR, Watson MA, McKee DD, Moore LB, et al. A regulatory cascade of the nuclear receptors FXR, SHP-1, and LRH-1 represses bile acid biosynthesis. Mol Cell. 2000;6:517\u201326. https:\/\/doi.org\/10.1016\/s1097-2765(00)00051-4.","journal-title":"Mol Cell"},{"key":"948_CR31","doi-asserted-by":"publisher","first-page":"507","DOI":"10.1016\/s1097-2765(00)00050-2","volume":"6","author":"TT Lu","year":"2000","unstructured":"Lu TT, Makishima M, Repa JJ, Schoonjans K, Kerr TA, Auwerx J, et al. Molecular basis for feedback regulation of bile acid synthesis by nuclear receptors. Mol Cell. 2000;6:507\u201315. https:\/\/doi.org\/10.1016\/s1097-2765(00)00050-2.","journal-title":"Mol Cell"},{"key":"948_CR32","doi-asserted-by":"publisher","first-page":"15482","DOI":"10.1074\/jbc.275.20.15482","volume":"275","author":"C Yu","year":"2000","unstructured":"Yu C, Wang F, Kan M, Jin C, Jones RB, Weinstein M, et al. Elevated cholesterol metabolism and bile acid synthesis in mice lacking membrane tyrosine kinase receptor FGFR4. J Biol Chem. 2000;275:15482\u20139. https:\/\/doi.org\/10.1074\/jbc.275.20.15482.","journal-title":"J Biol Chem"},{"key":"948_CR33","doi-asserted-by":"publisher","first-page":"E833","DOI":"10.1152\/ajpendo.00182.2018","volume":"315","author":"E Somm","year":"2018","unstructured":"Somm E, Henry H, Bruce SJ, Bonnet N, Montandon SA, Niederl\u00e4nder NJ, et al. \u03b2-Klotho deficiency shifts the gut-liver bile acid axis and induces hepatic alterations in mice. Am J Physiol Endocrinol Metab. 2018;315:E833\u201347. https:\/\/doi.org\/10.1152\/ajpendo.00182.2018.","journal-title":"Am J Physiol Endocrinol Metab"},{"key":"948_CR34","doi-asserted-by":"publisher","first-page":"1832","DOI":"10.1158\/1535-7163.MCT-18-0048","volume":"18","author":"R Bartz","year":"2019","unstructured":"Bartz R, Fukuchi K, Ohtsuka T, Lange T, Gruner K, Watanabe I, et al. Preclinical development of U3\u20131784, a novel FGFR4 antibody against cancer, and avoidance of its on-target toxicity. Mol Cancer Ther. 2019;18:1832\u201343. https:\/\/doi.org\/10.1158\/1535-7163.MCT-18-0048.","journal-title":"Mol Cancer Ther"},{"key":"948_CR35","doi-asserted-by":"publisher","first-page":"265","DOI":"10.1093\/toxsci\/kfy031","volume":"163","author":"HS Schadt","year":"2018","unstructured":"Schadt HS, Wolf A, Mahl JA, Wuersch K, Couttet P, Schwald M, et al. Bile acid sequestration by cholestyramine mitigates FGFR4 inhibition-induced ALT elevation. Toxicol Sci. 2018;163:265\u201378. https:\/\/doi.org\/10.1093\/toxsci\/kfy031.","journal-title":"Toxicol Sci"},{"key":"948_CR36","doi-asserted-by":"publisher","first-page":"LB-272","DOI":"10.1158\/1538-7445.Am2018-lb-272","volume":"78","author":"Z Chen","year":"2018","unstructured":"Chen Z. Discovery and characterization of a novel FGFR4 Inhibitor for the treatment of hepatocellular carcinoma [abstract]. Cancer Res. 2018;78:LB-272. https:\/\/doi.org\/10.1158\/1538-7445.Am2018-lb-272.","journal-title":"Cancer Res"},{"key":"948_CR37","doi-asserted-by":"publisher","first-page":"4090","DOI":"10.1200\/JCO.2021.39.15_suppl.4090","volume":"39","author":"T Macarulla","year":"2021","unstructured":"Macarulla T, Moreno V, Chen LT, Sawyer MB, Goyal L, Mu\u00f1oz Mart\u00edn AJ, et al. Phase I study of H3B\u20136527 in hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC). J Clin Oncol. 2021;39:4090. https:\/\/doi.org\/10.1200\/JCO.2021.39.15_suppl.4090.","journal-title":"J Clin Oncol"}],"container-title":["Targeted Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11523-023-00948-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s11523-023-00948-8\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11523-023-00948-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,4,6]],"date-time":"2023-04-06T15:09:31Z","timestamp":1680793771000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s11523-023-00948-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,2,14]]},"references-count":37,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2023,3]]}},"alternative-id":["948"],"URL":"https:\/\/doi.org\/10.1007\/s11523-023-00948-8","relation":{},"ISSN":["1776-2596","1776-260X"],"issn-type":[{"value":"1776-2596","type":"print"},{"value":"1776-260X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,2,14]]},"assertion":[{"value":"26 January 2023","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"14 February 2023","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This research was funded by Incyte Corporation and, in part, through the NIH\/NCI Cancer Center Support Grant P30 CA008748 (JJH).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"James J. Harding: Consulting or advisory role for Adaptimmune, Bristol Myers Squibb, CytomX, Eisai, Eli Lilly & Company, Exelixis, Imvax, Merck, Zymeworks; and research funding from Boehringer Ingelheim (Inst), Bristol Myers Squibb (Inst), Calithera Biosciences (Inst), Debiopharm (Inst), Eli Lilly & Company (Inst), Incyte Corporation (Inst), Novartis (Inst), Pfizer (Inst), Polaris Group (Inst), Yiviva (Inst), and Zymeworks (Inst). Christiane Jungels: Travel, accommodations, and expenses from Ipsen, PharmaMar. Jean-Pascal Machiels: Consulting or advisory role for ALX Oncology, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CUE Biopharma, Debiopharm, Incyte Corporation, Innate Pharma, Janssen, Merck Serono, Merck Sharp & Dohme, Nanobiotix, Novartis, Pfizer, Roche; research funding from Bayer, Janssen, Novartis, Sanofi; and travel, accommodations, and expenses from Amgen, Bristol Myers Squibb, Merck Sharp & Dohme, and Pfizer. David C. Smith: Research funding from Agensys (Inst), Atterocor (Inst), Bayer (Inst), Boston Biomedical (Inst), Bristol Myers Squibb\/Medarex (Inst), Celgene (Inst), Eli Lilly & Company (Inst), ESSA (Inst), Exelixis (Inst), Genentech (Inst), ImClone Systems (Inst), Incyte Corporation (Inst), MedImmune (Inst), Medivation\/Astellas Pharma (Inst), Millennium Pharmaceuticals (Inst), Novartis (Inst), OncoGenex (Inst), OncoMed Pharmaceuticals (Inst), Regeneron (Inst), SeaGen (Inst), Takeda (Inst), Tekmira Pharmaceuticals (Inst), and Teva Pharmaceuticals (Inst). Chris Walker, Tao Ji, Pin Jiang: Former employees of Incyte Corporation. Ekaterine Asatiani, Xin Li: Employment by, and stock ownership in, Incyte Corporation. Eric Van Cutsem: Consulting or advisory role for Array BioPharma, AstraZeneca, Bayer, Biocartis, Bristol Myers Squibb, Celgene, Daiichi Sankyo, Eli Lilly & Company, GlaxoSmithKline, Halozyme, Incyte Corporation, Merck KGaA, Merck Sharp & Dohme, Novartis, Pierre Fabre, Roche, Servier, Sirtex Medical, and Taiho Pharmaceutical Co., Ltd; and research funding from Amgen (Inst), Bayer (Inst), Boehringer Ingelheim (Inst), Bristol Myers Squibb (Inst), Celgene (Inst), Eli Lilly & Company (Inst), Ipsen (Inst), Merck (Inst), Merck KGaA (Inst), Novartis (Inst), Roche (Inst), and Servier (Inst). Ghassan K. Abou-Alfa: Research grants from Arcus, AstraZeneca, BioNtech, Bristol Myers Squibb, Celgene, Flatiron Health, Genentech\/Roche, Genoscience Pharma, Incyte Corporation, Polaris Group, Puma Biotechnology, QED Therapeutics, Silenseed, Yiviva; and consultancy with Adicet Bio, Alnylam Pharmaceuticals, AstraZeneca, Autem Therapeutics, BeiGene, Berry Genomics, Boehringer Ingelheim, Celgene, Cend Therapeutics, CytomX, Eisai, Eli Lilly & Company, Exelixis, Flatiron Health, Genentech\/Roche, Genoscience Pharma, Helios Pharmaceuticals, Helsinn Group, Incyte Corporation, Ipsen, Merck, Nerviano Medical Sciences, NewBridge Pharmaceuticals, Novartis, QED Therapeutics, Redhill, Rafael Pharmaceuticals, Servier, Silenseed, Sobi, Vector Pharma, and Yiviva.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Incyte Corporation (Wilmington, DE, USA) is committed to data sharing that advances science and medicine while protecting patient privacy. Qualified external scientific researchers may request anonymized datasets owned by Incyte for the purpose of conducting legitimate scientific research. Researchers may request anonymized datasets from any interventional study (except phase I studies) for which the product and indication have been approved on or after 1 January 2020 in at least one major market (e.g., United States, European Union, Japan). Data will be available for request after the primary publication or 2 years after the study has ended. Information on Incyte\u2019s clinical trial data sharing policy and instructions for submitting clinical trial data requests are available at: .","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"The study, registered under ClinicalTrials.gov (NCT03144661), was performed in accordance with the International Conference for Harmonization Good Clinical Practice guidelines, the Declaration of Helsinki, and applicable local regulations with approval from institutional review boards. The study protocol was reviewed and approved by the respective institutional review boards of the participating institutions (Online Supplementary Table 1).","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Written informed consent was obtained for all patients before performing study-related procedures.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"All authors were responsible for data collection, data integrity and analyses, and data interpretation, and reviewed and edited the manuscript. The corresponding author wrote the initial draft manuscript, had full access to all study data, and had final responsibility for the decision to submit for publication.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}