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Ref Type Journal Article
PMID (37956738)
Authors Necchi A, Pouessel D, Leibowitz R, Gupta S, Fléchon A, García-Donas J, Bilen MA, Debruyne PR, Milowsky MI, Friedlander T, Maio M, Gilmartin A, Li X, Veronese ML, Loriot Y
Title Pemigatinib for Metastatic or Surgically Unresectable Urothelial Carcinoma With FGF/FGFR Genomic Alterations: Final Results From FIGHT-201.
Journal Vol Issue Date Pages Journal Short Title
Annals of oncology : official journal of the European Society for Medical Oncology 2023 Nov 11 Ann Oncol
URL
Abstract Text Fibroblast growth factor receptor 3 (FGFR3) alterations are oncogenic drivers of urothelial carcinoma (UC). Pemigatinib is a selective, oral inhibitor of FGFR1-3 with antitumor activity. We report the efficacy and safety of pemigatinib in the open-label, single-arm phase 2 study of previously treated, unresectable or metastatic UC with FGFR3 alterations (FIGHT-201; NCT02872714).Patients ≥18 years old with FGFR3 mutations or fusions/rearrangements (cohort A) and other FGF/FGFR alterations (cohort B) were included. Patients received pemigatinib 13.5 mg once daily continuously (CD) or intermittently (ID) until disease progression or unacceptable toxicity. The primary endpoint was centrally confirmed objective response rate (ORR) per RECIST v1.1 in cohort A-CD. Secondary endpoints included ORR in cohorts A-ID and B, duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.Overall, 260 patients were enrolled and treated (A-CD, n=101; A-ID, n=103; B, n=44; unconfirmed FGF/FGFR status, n=12). All discontinued treatment, most commonly due to progressive disease (68.5%). ORR (95% CI) in cohorts A-CD and A-ID was 17.8% (10.9%, 26.7%) and 23.3% (15.5%, 32.7%), respectively. Among patients with the most common FGFR3 mutation (S249C; n=107), ORR was similar between cohorts (A-CD, 23.9%; A-ID, 24.6%). In cohorts A-CD/A-ID, median (95% CI) DOR was 6.2 (4.1, 8.3)/6.2 (4.6, 8.0) months, PFS was 4.0 (3.5, 4.2)/4.3 (3.9, 6.1) months, and OS was 6.8 (5.3, 9.1)/8.9 (7.5, 15.2) months. Pemigatinib had limited clinical activity among patients in cohort B. Of 36 patients with samples available at progression, 6 patients had 8 acquired FGFR3 secondary resistance mutations (V555M/L, n=3; V553M, n=1; N540K/S, n=2; M528I, n=2). The most common treatment-emergent adverse events overall were diarrhea (44.6%) and alopecia, stomatitis, and hyperphosphatemia (42.7% each).Pemigatinib was generally well tolerated and demonstrated clinical activity in previously treated, unresectable or metastatic UC with FGFR3 mutations or fusions/rearrangements.

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