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 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:


Disease control rate (CR+PR+SD)


Best overall response*


Confirmed overall 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 overall 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


  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.
  • Sign Up

    Stay up to date.

    Receive updates on the development of infigratinib and breaking news from QED Therapeutics.

    *Required fields.

  • Communication Agreement

    By completing this form and clicking the SUBMIT button, you understand and hereby consent to your personal information being stored on a database in the United States and accessible to QED Therapeutics for purposes such as marketing programs from QED Therapeutics, disseminating information about research from QED Therapeutics regarding infigratinib and related health conditions, and obtaining feedback about our products and services. You may request access to, removal, or correction of your personal information by sending an email to: info@QEDTx.com. Please review the full QED Therapeutics privacy policy for more information on your rights with respect to your personal information. If you are a resident of the European Union, please note that by submitting your information to QED through this form, you are expressly consenting to transfer of your personal data to the United States.

  • This field is for validation purposes and should be left unchanged.

Contact Us

75 Federal Street
San Francisco, CA 94107