FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with <i>FGFR2</i> 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 Lihou, Hui‐Ling 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)