國家衛生研究院 NHRI:Item 3990099045/14180
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    题名: Primary results of phase 2 FOENIX-CCA2: the irreversible FGFR1-4 inhibitor futibatinib in intrahepatic cholangiocarcinoma (iCCA) with FGFR2 fusions/rearrangements
    作者: Mohler, M;Goyal, L;Meric-Bernstam, F;Hollebecque, A;Morizane, C;Valle, JW;Karasic, TB;Abrams, TA;Kelley, RK;Cassier, P;Furuse, J;Klumpen, HJ;Chang, HM;Chen, LT;Komatsu, Y;Masuda, K;Ahn, D;He, Y;Soni, N;Benhadji, KA;Bridgewater, JA
    贡献者: National Institute of Cancer Research
    摘要: Background: FGFR2 fusions occur in ~15% of patients (pts) with iCCA, a rare cancer with a poor prognosis. Futibatinib, a highly selective, irreversible FGFR1-4 inhibitor, has shown activity across tumor types, including iCCA, in a phase 1 study. The pivotal phase 2 FOENIX-CCA2 trial (NCT02052778) is evaluating futibatinib in iCCA harboring FGFR2 fusions/rearrangements. Here, we report the first efficacy, safety, and biomarker data for the complete FOENIX-CCA2 population. Methods: Eligible pts had unresectable/metastatic iCCA with an FGFR2 fusion/rearrangement and progressive disease (PD) after ≥1 prior treatment (tx; excluding FGFR inhibitors). Pts received futibatinib 20 mg QD until PD/intolerability. The primary endpoint was objective response rate (ORR) per RECIST v1.1 by independent central review (target ORR: 20%). Secondary endpoints included duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.
    日期: 2021-09
    關聯: Oncology Research and Treatment. 2021 Sep;44(Suppl. 2):222.
    Link to: https://doi.org/10.1159/000518417
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=2296-5270&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000760622600406
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