The phase 2 FOENIX-CCA2 clinical trial evaluated the investigational FGFR1-4 inhibitor futibatinib in patients with advanced intrahepatic cholangiocarcinoma (CCA) harboring FGFR2 fusion or other rearrangements.
In the absence of head-to-head clinical trials comparing the currently available FGFR inhibitors, Mitesh J. Borad, MD, Mayo Clinic, Phoenix, AZ, and colleagues conducted an indirect treatment comparison of efficacy outcomes that have been previously published with futibatinib therapy from the FOENIX-CCA2 study versus outcomes with chemotherapy plus FGFR inhibitors. Dr Borad presented the results at the 2022 ASCO GI Cancers Symposium.
This systematic literature review identified clinical trials with FGFR inhibitors that were published between January 2015 and February 2021, and used additional targeted searches for chemotherapy data. Dr Borad and colleagues used the population-adjusted simulated treatment comparison method, and applied individual-level patient data from FOENIX-CCA2 as well as published aggregate data from comparator clinical trials, adjusting for between-study differences in baseline characteristics.
Population-adjusted Cox regression models were used for base-case time-to-event outcomes, including progression-free survival (PFS), overall survival (OS), duration of response (DOR), and binomial-logistic regressions for binary outcomes, namely, objective response rate (ORR).
Two studies were identified for FGFR inhibitors in previously treated patients with FGFR2 fusion or other rearrangements—FOENIX-CCA2 for futibatinib (N = 103) and FIGHT-202 for pemigatinib (N = 107). For chemotherapy in this setting, 2 studies were identified—an analysis of previous systemic therapy in the FIGHT-202 cohort (N = 53), and a natural history study using a clinico-genomic database (N = 71).
In the base-case analysis of futibatinib versus chemotherapy, the patients who received futibatinib had a significantly longer PFS compared with chemotherapy (hazard ratio [HR], 0.53) and OS (HR, 0.49). In the base-case comparisons of futibatinib versus pemigatinib, treatment with futibatinib was associated with a numerical advantage for all the efficacy parameters, including PFS (HR, 0.89), OS (HR, 0.83), DOR (HR, 0.75), and ORR (HR, 1.43); however, these outcomes did not reach statistical significance.
These data show that futibatinib provides survival advantage compared with chemotherapy in previously treated patients with advanced intrahepatic CCA harboring FGFR2 fusion or other rearrangements. In addition, although significant differences in efficacy outcomes were not found between futibatinib and pemigatinib, the numerical trends favored futibatinib over pemigatinib in patients with intrahepatic CCA, Dr Borad noted.
Borad MJ, Paine A, Wacheck V, et al. Indirect treatment comparison of futibatinib with chemotherapy and pemigatinib in cholangiocarcinoma with FGFR2 fusions/rearrangements. Abstract 440.
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