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

Future Oncol. 2020 Oct;16(30):2385-2399. doi: 10.2217/fon-2020-0429. Epub 2020 Jul 17.

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.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Bile Duct Neoplasms / diagnosis
  • Bile Duct Neoplasms / drug therapy*
  • Bile Duct Neoplasms / genetics*
  • Bile Duct Neoplasms / mortality
  • Biomarkers, Tumor
  • Cholangiocarcinoma / diagnosis
  • Cholangiocarcinoma / drug therapy*
  • Cholangiocarcinoma / genetics*
  • Cholangiocarcinoma / mortality
  • Cisplatin / administration & dosage
  • Clinical Protocols
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / analogs & derivatives
  • Female
  • Gemcitabine
  • Gene Rearrangement*
  • Humans
  • Male
  • Molecular Targeted Therapy
  • Morpholines / administration & dosage
  • Morpholines / adverse effects
  • Morpholines / therapeutic use*
  • Mutation
  • Pyrimidines / administration & dosage
  • Pyrimidines / adverse effects
  • Pyrimidines / therapeutic use*
  • Pyrroles / administration & dosage
  • Pyrroles / adverse effects
  • Pyrroles / therapeutic use*
  • Receptor, Fibroblast Growth Factor, Type 2 / genetics*
  • Research Design
  • Treatment Outcome

Substances

  • Biomarkers, Tumor
  • Morpholines
  • Pyrimidines
  • Pyrroles
  • Deoxycytidine
  • FGFR2 protein, human
  • Receptor, Fibroblast Growth Factor, Type 2
  • Cisplatin
  • pemigatinib
  • Gemcitabine

Associated data

  • ClinicalTrials.gov/NCT03656536