Futibatinib, a highly selective, irreversible FGFR1-4 inhibitor, was evaluated in a large multihistology phase I dose-expansion trial that enrolled 197 patients with advanced solid tumors. It was not a specifically colon cancer study. The greatest activity was observed in FGFR2 fusion/rearrangement-positive intrahepatic cholangiocarcinoma (ORR, 25.4%) andFDA approvied it for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (bile duct cancer) harboring FGFR2 gene fusions or other rearrangements.This phase I dose-expansion trial demonstrated clinical activity and tolerability of the irreversible FGFR1-4 inhibitor futibatinib across a broad spectrum of FGFR-aberrant tumors. These results formed the rationale for ongoing phase II/III futibatinib trials in cholangiocarcinoma, breast cancer, gastroesophageal cancer, and a genomically selected disease-agnostic population. As such, the proposed treatment is E/I.
Meric-Bernstam F, Bahleda R, Hierro C, Sanson M, Bridgewater J, Arkenau HT, Tran B, Kelley RK, Park JO, Javle M, He Y, Benhadji KA, Goyal L. Futibatinib, an Irreversible FGFR1-4 Inhibitor, in Patients with Advanced Solid Tumors Harboring FGF/FGFR Aberrations: A Phase I Dose-Expansion Study. Cancer Discov. 2022 Feb;12(2):402-415. doi: 10.1158/2159-8290.CD-21-0697. Epub 2021 Sep 22. PMID: 34551969; PMCID: PMC9762334.
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