{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,8,22]],"date-time":"2025-08-22T05:11:50Z","timestamp":1755839510942},"reference-count":28,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2023,3,31]],"date-time":"2023-03-31T00:00:00Z","timestamp":1680220800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100017655","name":"Incyte","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100017655","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2023,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>FIGHT\u2010102 was a phase 1, dose\u2010escalation, dose\u2010expansion study of pemigatinib in Japanese patients with advanced solid tumors. Here, we report safety, tolerability, and preliminary efficacy of pemigatinib from FIGHT\u2010102.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients (\u226520\u2009years old) self\u2010administered oral pemigatinib 9, 13.5, or 18\u2009mg QD on intermittent dosing (Part 1) or 13.5 mg QD intermittent or continuous dosing (Part 2). A dosing cycle was 21\u2009days (2\u2009weeks on\/1 week off or 21 continuous days). Primary endpoint was safety. Secondary endpoints were pharmacokinetics, pharmacodynamics, and preliminary efficacy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Forty\u2010four patients (Part 1, <jats:italic>n<\/jats:italic>\u00a0=\u00a014; Part 2, <jats:italic>n<\/jats:italic>\u00a0=\u00a030) were enrolled; most common tumors, cholangiocarcinoma, <jats:italic>n<\/jats:italic>\u00a0=\u00a08; esophageal, <jats:italic>n<\/jats:italic>\u00a0=\u00a06; 26 patients had confirmed <jats:italic>FGF\/FGFR<\/jats:italic> alterations (Part 1, <jats:italic>n<\/jats:italic>\u00a0=\u00a03; Part 2, <jats:italic>n<\/jats:italic>\u00a0=\u00a023); 70.5% had \u22653 prior systemic therapies. Maximum tolerated dose was not identified. The recommended phase 2 dosage was determined to be 13.5 mg QD. Most common treatment\u2010emergent adverse events (TEAEs) were hyperphosphatemia (81.8%), dysgeusia (45.5%), stomatitis (43.2%), and alopecia (38.6%); most frequent Grade\u2009\u22653 TEAEs were anemia and decreased appetite (9.1% each). In Part 1, no patient achieved partial response (PR) or complete response, and 7 (50.0%) patients had stable disease (SD). In Part 2, 5 (16.7%) patients achieved PR (one each with cholangiocarcinoma, gall bladder cancer, breast cancer, urothelial tract\/bladder cancer, and sweat gland carcinoma) and 6 (20%) had SD. Median duration of response was 9.56\u2009months (95% CI: 4.17, 14.95).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Pemigatinib demonstrated manageable adverse events, consistent pharmacokinetics and pharmacodynamics profiles, and preliminary efficacy in Japanese patients with advanced solid tumors.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cam4.5798","type":"journal-article","created":{"date-parts":[[2023,3,31]],"date-time":"2023-03-31T14:15:21Z","timestamp":1680272121000},"page":"10597-10611","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["<scp>FIGHT<\/scp>\u2010102: A phase 1 study of pemigatinib in Japanese patients with advanced malignancies"],"prefix":"10.1002","volume":"12","author":[{"given":"Yutaka","family":"Fujiwara","sequence":"first","affiliation":[{"name":"National Cancer Center Hospital  Tokyo Japan"},{"name":"Aichi Cancer Center  Nagoya Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasutoshi","family":"Kuboki","sequence":"additional","affiliation":[{"name":"National Cancer Central Hospital East  Chiba Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masayuki","family":"Furukawa","sequence":"additional","affiliation":[{"name":"Kyushu Cancer Center  Fukuoka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nobumasa","family":"Mizuno","sequence":"additional","affiliation":[{"name":"Aichi Cancer Center  Nagoya Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroki","family":"Hara","sequence":"additional","affiliation":[{"name":"Saitama Cancer Center  Saitama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tatsuya","family":"Ioka","sequence":"additional","affiliation":[{"name":"Department of Oncology Center Yamaguchi University Hospital  Ube Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Makoto","family":"Ueno","sequence":"additional","affiliation":[{"name":"Kanagawa Cancer Center  Yokohama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasuo","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Hokkaido Cancer Center  Sapporo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shunji","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Cancer Institute Hospital of JFCR  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shinji","family":"Takeuchi","sequence":"additional","affiliation":[{"name":"Kanazawa University Hospital  Kanazawa Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christine","family":"Lihou","sequence":"additional","affiliation":[{"name":"Incyte Corporation  Wilmington Delaware USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tao","family":"Ji","sequence":"additional","affiliation":[{"name":"Incyte Corporation  Wilmington Delaware USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chenwei","family":"Tian","sequence":"additional","affiliation":[{"name":"Incyte Corporation  Wilmington Delaware USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshio","family":"Shimizu","sequence":"additional","affiliation":[{"name":"National Cancer Center Hospital  Tokyo Japan"},{"name":"Wakayama Medical University  Wakayama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,3,31]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41392-020-00222-7"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.18632\/oncotarget.14109"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.3390\/cells10061342"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms21186856"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2016-10-695973"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41416-020-01157-0"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-18-0078"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/ajh.26352"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.26890"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0231877"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2022.02.001"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2021.39.15_suppl.4086"},{"key":"e_1_2_10_14_1","unstructured":"European Medicines Agency.2021.Pemazyre\u00ae(pemigatinib). 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