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dc.contributor.authorBekaii-Saab, T. S.
dc.contributor.authorValle, Juan W
dc.contributor.authorVan Cutsem, E.
dc.contributor.authorRimassa, L.
dc.contributor.authorFuruse, J.
dc.contributor.authorIoka, T.
dc.contributor.authorMelisi, D.
dc.contributor.authorMacarulla, T.
dc.contributor.authorBridgewater, J. A.
dc.contributor.authorWasan, H. S.
dc.contributor.authorBorad, M. J.
dc.contributor.authorLihou, C. F.
dc.contributor.authorZhen, H. L.
dc.contributor.authorFeliz, L.
dc.contributor.authorAsatiani, E.
dc.contributor.authorJiang, P.
dc.contributor.authorVogel, A.
dc.date.accessioned2020-06-16T11:03:16Z
dc.date.available2020-06-16T11:03:16Z
dc.date.issued2020en
dc.identifier.citationT. S. Bekaii-Saab, J. W. Valle, E. Van Cutsem et al. FIGHT-302: Phase III study of first-line (1L) pemigatinib (PEM) versus gemcitabine (GEM) plus cisplatin (CIS) for cholangiocarcinoma (CCA) with FGFR2 fusions or rearrangements. Journal of Clinical Oncology. 2020;38(4)en
dc.identifier.urihttp://hdl.handle.net/10541/623038
dc.description.abstractBackground: For advanced CCA, standard of care 1L systemic treatment is GEM + CIS. Genetic alterations in intrahepatic CCA provide potential therapeutic targets. Fibroblast growth factor receptor (FGFR) 2 gene rearrangements driving CCA tumorigenesis were identified almost exclusively in intrahepatic CCA patients (pts) (incidence, 10?16%). In phase 2, PEM (INCB054828), a selective, potent, oral FGFR1?3 inhibitor elicited an objective response rate (ORR) of 35.5% and median progression-free survival (PFS) of 6.9 months (mo) in previously treated, locally advanced or metastatic CCA with FGFR2 rearrangements (NCT02924376). FIGHT-302, a randomized, open-label, phase 3 study will evaluate efficacy and safety of 1L PEM vs GEM + CIS in unresectable/metastatic CCA with FGFR2 fusions or rearrangements (NCT03656536). Methods: Eligible pts are adults with confirmed unresectable/metastatic CCA; no prior systemic therapy for advanced disease < 6 mo before enrollment; radiographically measurable/evaluable disease (per RECIST v1.1); ECOG PS ?1; documented FGFR2 fusions or rearrangements. Exclusions include clinically significant corneal or retinal disorder; history of calcium and phosphate homeostasis disorder or systemic mineral imbalance with ectopic soft tissue calcification; untreated CNS metastases or history of uncontrolled seizures. Pts will be randomized (1:1; stratified by region and tumor burden) to PEM 13.5 mg QD on a 21-day (d) cycle or GEM (1000 mg/m2) + CIS (25 mg/m2) on D1 and D8 of 21-d cycles (max 8). Crossover to PEM allowed after confirmed progression. PEM titration to 18 mg from cycle 2 allowed for pts without hyperphosphatemia (serum phosphate > 5.5 mg/dL) and Grade ?2 treatment-related adverse events during cycle 1. Hyperphosphatemia will be managed with diet modifications, phosphate binders, diuretics, or dose adjustments. Treatment will continue until progression or unacceptable toxicity. Primary endpoint is PFS (by independent review). Secondary endpoints are ORR, overall survival, duration of response, disease control rate, safety, and quality of life. Four pts (target N = 432) are enrolled as of Sep 25, 2019. Clinical trial information: NCT03656536.en
dc.language.isoenen
dc.titleFIGHT-302: Phase III study of first-line (1L) pemigatinib (PEM) versus gemcitabine (GEM) plus cisplatin (CIS) for cholangiocarcinoma (CCA) with FGFR2 fusions or rearrangementsen
dc.typeMeetings and Proceedingsen
dc.contributor.departmentMayo Clinic, Phoenix, AZen
dc.identifier.journalJournal of Clinical Oncologyen
dc.description.noteen]


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