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In biliary cancers that harbor fibroblast growth factor receptor 2 (FGFR2) gene fusions or rearrangements, inhibitors of FGFR2 have significant and often durable activity. Investigators now report the results of an international, industry-sponsored, open-label, phase 2 trial of futibatinib — an oral irreversible inhibitor of FGFR2 — in patients with previously treated advanced biliary cancer with FGFR2 alterations.
Of 798 patients with intrahepatic cholangiocarcinoma undergoing tissue-based screening, 103 with FGFR2 alterations were enrolled and treated with futibatinib (20 mg daily). The median age was 58, most patients (56%) were female, most (78%) had FGFR2 gene fusions as opposed to rearrangements (22%), and most (51%) had received 2 or …