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Results from FIGHT-201 trial showed clinical activity for pemigatinib in metastatic or surgically unresectable urothelial carcinoma with FGF/FGFR alterations
Final results of FIGHT-201 trial, recently published on Annals of Oncology, showed that pemigatinib, a selective, oral inhibitor of Fibroblast growth factor receptor 3 (FGFR1-3), is well tolerated and has clinical antitumor activity in previously treated, unresectable or metastatic urothelial carcinoma with FGFR3 mutations or fusions/rearrangements.
FIGHT-201 study is an open-label, single-arm, phase II multicenter trial including 270 patients with previously treated, unresectable or metastatic urothelial carcinoma with FGFR3 alterations. Patients received pemigatinib 13.5 mg once daily continuously or intermittently until disease progression or unacceptable toxicity. Results showed an objective response rate of 17.8% and 23.3% in continuously and intermittently treated patients, respectively; objective response rate was similar in both cohorts among patients with the most common FGFR3 mutation. Median duration of response was 6.2 months, progression-free survival was 4 months and overall survival was 6.8 months; limited clinical benefit was observed in patients with FGF/FGFR alterations other than FGFR3 mutation. All discontinued treatment, most commonly due to progressive disease (68.5%); of 36 patients with samples available at progression, 6 patients had 8 acquired FGFR3 secondary resistance mutations. «Consistent with the efficacy of pemigatinib in advanced cholangiocarcinoma with FGFR2 fusions or rearrangements and other solid tumors with FGF/FGFR alterations, in this analysis of final data from FIGHT-201 pemigatinib demonstrated clinical activity and manageable adverse events in patients with previously treated unresectable urothelial carcinoma or metastatic urothelial carcinoma and FGFR3 alterations irrespective of dosing regimen», authors conclude.