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, 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

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.

Figures

Figure 1.. FIGHT-302 study schema.
Figure 1.. FIGHT-302 study schema.
CCA: Cholangiocarcinoma; CR: Complete response; ECOG PS: Eastern Cooperative Oncology Group performance status; PD: Progressive disease; PR: Partial response; QD: Once daily; SD: Stable disease.

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