| Autor: |
Bekaii-Saab TS; Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Phoenix, AZ 85054, USA., Valle JW; Division of Cancer Sciences, University of Manchester & Department of Medical Oncology, The Christie Hospital NHS Foundation Trust, The University of Manchester, Manchester, UK., Van Cutsem E; Department of Oncology, University of Leuven, Leuven, Belgium., Rimassa L; Department of Oncology and Hematology, Humanitas Clinical and Research Center-IRCCS, Rozzano, Milan, Italy.; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy., Furuse J; Department of Medical Oncology, Kyorin University, Tokyo, Japan., Ioka T; Department of Cancer Survey and Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan., Melisi D; Department of Medicine, University of Verona, Verona, Italy., Macarulla T; Medical Oncology Department, Vall d'Hebron University Hospital & Vall d'Hebron Institute of Oncology, Barcelona, Spain., Bridgewater J; Research Department of Oncology, UCL Cancer Institute, University College London, London, UK., Wasan H; Department of Medical Oncology, Hammersmith Hospital, Imperial College Health Care Trust, London, UK., Borad MJ; Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Phoenix, AZ 85054, USA., Abou-Alfa GK; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.; Department of Medicine, Weill Medical College, Cornell University, New York, NY, USA., Jiang P; Incyte Corporation, Wilmington, DE, USA., Lihou CF; Incyte Corporation, Wilmington, DE, USA., Zhen H; Incyte Corporation, Wilmington, DE, USA., Asatiani E; Incyte Biosciences International Sàrl, Morges, Switzerland., Féliz L; Incyte Biosciences International Sàrl, Morges, Switzerland., Vogel A; Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany. |
| Abstrakt: |
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). |
