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 language | English (US) |
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Pages (from-to) | 2385-2399 |
Number of pages | 15 |
Journal | Future Oncology |
Volume | 16 |
Issue number | 30 |
DOIs | |
State | Published - Oct 2020 |
Keywords
- FGFR
- INCB054828
- cholangiocarcinoma
- pemigatinib
ASJC Scopus subject areas
- Oncology
- Cancer Research