ナカイ　ヨウスケ   NAKAI Yousuke   中井　陽介    所属   医学部 医学科（東京女子医科大学病院）    職種   教授・基幹分野長
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	Tasurgratinib (E7090) for cholangiocarcinoma with fibroblast growth factor receptor 2 fusions/rearrangements: a multicenter, open-label, Phase 2 study
掲載誌名	正式名：Japanese journal of clinical oncology 略　 称：Jpn J Clin Oncol ISSNコード：14653621/03682811
掲載区分	国内
巻・号・頁	55(11),pp.1229-1236
著者・共著者	Lin Shen, Huaxin Duan, KUWAHARA Takamichi, SATOH Taroh, Xuelei Ma, Sheng Yan, Haitao Zhao,IKEDA Masafumi, Tongjian Cui,SASAKI Takashi, Zhiqiang Meng,NAKAI Yosuke,UENO Makoto,KOMATSU Yoshito,NAGANO Hiroaki,MORIZANE Chigusa,FUNASAKA Setsuo,IKEZAWA Hiroki,NAKADA Takuya,FURUSE Junji
発行年月	2025/11
概要	BACKGROUND:This Phase 2 study (NCT04238715) evaluated the efficacy/safety of tasurgratinib 140 mg daily in patients with cholangiocarcinoma (CCA) and fibroblast growth factor receptor (FGFR) 2 fusions/rearrangements.METHODS:Eligible Japanese and Chinese patients who had surgically unresectable, advanced, or metastatic CCA and had received ≥1 prior gemcitabine-based combination chemotherapy regimen were included and treated with oral tasurgratinib 140 mg daily. The primary endpoint was objective response rate (ORR); the study was considered successful if the lower limit of the ORRs 90% CI was >15%. Secondary endpoints included duration of response and safety. FGFR2 fusions/rearrangements were confirmed by fluorescence in situ hybridization performed in central laboratories. Tumor responses were measured every 8 weeks by Response Evaluation Criteria in Solid Tumors version 1.1 per independent imaging review.RESULTS:Sixty-three patients were treated; 23 (37%) had received 1 prior regimen, all others had received ≥2. By the data cutoff date (15 March 2023), the ORR was 30.2% (two-sided 90% CI: 20.7-41.0). The median duration of response for responders was 5.6 months (95% CI: 3.7-9.3; range: 1.0+ to 14.8+). Sixty-one patients (97%) had ≥1 treatment-related treatment-emergent adverse event; 18 patients (29%) had ≥1 grade ≥3 treatment-related treatment-emergent adverse events. Four patients (6%) had a fatal adverse event, none were considered treatment-related. Tasurgratinib had promising antitumor activity in patients with CCA harboring FGFR2 fusions or rearrangements after ≥1 prior gemcitabine-based chemotherapy regimen.CONCLUSIONS:The primary endpoint (ORR) met the study's predefined success criteria. Tasurgratinib had a manageable safety profile consistent with previous reports and the known pharmacological profile of FGFR inhibitors.
DOI	10.1093/jjco/hyaf119
PMID	40795150