Urothelial Carcinoma
(Bladder Cancer)

FGFR3 genetic aberrations may be present in urothelial carcinoma, including

  • Approximately 20% of advanced urothelial carcinomas1
  • Up to 70% of upper tract urothelial carcinomas2
Infigratinib will be investigated in a clinical trial for previously treated urothelial carcinoma with FGFR3 aberrations.

Results from the expansion cohort of the prospective, single arm, open-label, Phase 1 study are presented here.3

FGFR=fibroblast growth factor receptor.

In 67 Patients With Previously Treated Metastatic Urothelial Carcinoma Containing FGFR3 Aberrations, Infigratinib Demonstrated3,4:

64%

Disease control rate (CR+PR+SD)

42%

Best overall response*

25%

Confirmed objective response rate

3.8 Months

Median progression-free survival

The primary objective of the study was to estimate the response rate associated with infigratinib. Assessment of disease control rate, best overall response, and progression-free survival were additional efficacy objectives.3

In the Phase 1 expansion cohort, the most common treatment-emergent adverse events (all grades) included hyperphosphatemia (46%), elevated creatinine (42%), fatigue (37%), constipation (37%), and anemia (36%).3 The adverse events observed with infigratinib were as expected based on published data for FGFR inhibitor therapies.3,5,6

  1. The best overall response is the best response recorded from the start of the study treatment until the end of treatment.
  2. The objective response rate is the sum of the CR rate and the PR rate, where CR is 100% reduction in target lesion size or complete tumor disappearance and PR is a ≥30% reduction in the sum of target lesion diameters.

CR=complete response; PR=partial response; SD=stable disease.

64% Disease Control Rate With Infigratinib (N=67)3


64% disease control rate in urothelial carcinoma with infigratinib

References

  1. Knowles MA, Hurst CD. Molecular biology of bladder cancer: new insights into pathogenesis and clinical diversity. Nat Rev Cancer. 2015;15(1):25-41.
  2. Moss TJ, Qi Y, Xi Liu, et al. Comprehensive genomic characterization of upper tract urothelial carcinoma. Eur Urol. 2017;72(4):641-649.
  3. Pal SK, Rosenberg JE, Hoffman-Censits JH, et al. Efficacy of BGJ398, a fibroblast growth factor receptor 1–3 inhibitor, in patients with previously treated advanced urothelial carcinoma with FGFR3 alterations. Cancer Disc. 2018;8(7):812-821.
  4. Data on file. 2018. QED Therapeutics.
  1. Necchi A, Pouessel D, Leibowitz-Amit R, et al. Interim results of fight-201, a phase 2, open-label, multicenter study of INCB054828 dosed intermittently in patients with metastatic or surgically unresectable urothelial carcinoma (UC) harboring fibroblast growth factor (FGF)/FGF receptor (FGFR) genetic alterations. Poster presented at: ESMO 2018 Congress; October 19-23, 2018; Munich, Germany.
  2. Joerger M, Cassier P, Penel N, et al. Rogaratinib treatment of patients with advanced urothelial carcinomas prescreened for tumor FGFR mRNA expression. J Clin Oncol. 2018:36(15 suppl):4513-4513. doi:10.1200/JCO.2018.36.15_suppl.4513.
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