FIGHT-302: First-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements

Tanios S. Bekaii-Saab, Juan W. Valle, Eric Van Cutsem, Lorenza Rimassa, Junji Furuse, Tatsuya Ioka, Davide Melisi, Teresa MacArulla, John Bridgewater, Harpreet Wasan, Mitesh J Borad, Ghassan K. Abou-Alfa, Ping Jiang, Christine F. Lihou, Huiling Zhen, Ekaterine Asatiani, Luis Féliz, Arndt Vogel

Research output: Contribution to journalReview articlepeer-review

1 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)2385-2399
Number of pages15
JournalFuture Oncology
Volume16
Issue number30
DOIs
StatePublished - Oct 2020

Keywords

  • cholangiocarcinoma
  • FGFR
  • INCB054828
  • pemigatinib

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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