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FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements
Bekaii-Saab, T. S. Valle, Juan W Cutsem, E. V. Rimassa, L. Furuse, J. Ioka, T. Melisi, D. Macarulla, T. Bridgewater, J. Wasan, H.
Bekaii-Saab, T. S.
Valle, Juan W
Cutsem, E. V.
Rimassa, L.
Furuse, J.
Ioka, T.
Melisi, D.
Macarulla, T.
Bridgewater, J.
Wasan, H.
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Abstract
FGFR2 rearrangements resulting in dysregulated signaling are drivers of cholangiocarcinoma (CCA) tumorigenesis, and occur almost exclusively in intrahepatic CCA. Pemigatinib, a selective, potent, oral inhibitor of FGFR1-3, has demonstrated efficacy and safety in a Phase II study of patients with previously treated locally advanced/metastatic CCA harboring FGFR2 fusions/rearrangements. We describe the study design of FIGHT-302, an open-label, randomized, active-controlled, multicenter, global, Phase III study comparing the efficacy and safety of first-line pemigatinib versus gemcitabine plus cisplatin in patients with advanced CCA with FGFR2 rearrangements (NCT03656536). The primary end point is progression-free survival; secondary end points are objective response rate, overall survival, duration of response, disease control rate, safety and quality of life. Clinical Trial Registration: NCT03656536 (ClinicalTrials.gov).
Keywords: FGFR; INCB054828; cholangiocarcinoma; pemigatinib.
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Date
2020
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Bekaii-Saab TS, Valle JW, Cutsem EV, Rimassa L, Furuse J, Ioka T, et al. FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements. Future Oncol. 2020.