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    Association details:
    Biomarker:FGFR3 mutation
    Cancer:Urothelial Cancer
    Drug:Truseltiq (infigratinib) (FGFR inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

    Excerpt:
    Incidence rate and category of dose-limiting toxicities will be tabulated for patients included in the dose escalation portion of the study, to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPTD) [ Time Frame: 23 months ]
    Trial ID:
    NCT01004224
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    J Urol
    Title:

    LBA01-10 INTERIM RESULTS FROM A PHASE 1B CLINICAL TRIAL EVALUATING TOLERABILITY AND ACTIVITY OF FGFR INHIBITION IN LOCALIZED UPPER TRACT UROTHELIAL CARCINOMA (UTUC)

    Published date:
    05/01/2022
    Excerpt:
    4 of 9 (44%) patients had a response with tumor reduction (range 25-83%); all responders had FGFR3 mutations….Infigratinib shows substantial activity in patients with localized UTUC bearing FGFR3 mutations, consistent with previous data in the metastatic setting.
    DOI:
    https://doi.org/10.1097/JU.0000000000002669.10
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ESMO 2019
    Title:

    cfDNA is an acceptable but insufficient means of characterizing FGFR3 mutation in patients with metastatic urothelial cancer (mUC)

    Published date:
    09/30/2019
    Excerpt:
    11 pts with progressive disease (PD) as a best response had detectable FGFR3 in cfDNA at screening, while this was found in only 7/12 responders (58%)...The paradoxically higher rate of PD in pts with detectable FGFR3 mutations in cfDNA warrants further study.
    DOI:
    10.1093/annonc/mdz249
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Cancer Discov
    Title:

    Efficacy of BGJ398, a Fibroblast Growth Factor Receptor 1-3 Inhibitor, in Patients with Previously Treated Advanced Urothelial Carcinoma with FGFR3 Alterations

    Excerpt:
    BJG398 is active in patients with alterations in FGFR3, resulting in both reductions in tumor volume and stabilization of disease.
    DOI:
    10.1158/2159-8290.CD-18-0229
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    J Clin Oncol
    Title:

    Evaluation of BGJ398, a Fibroblast Growth Factor Receptor 1-3 Kinase Inhibitor, in Patients With Advanced Solid Tumors Harboring Genetic Alterations in Fibroblast Growth Factor Receptors: Results of a Global Phase I, Dose-Escalation and Dose-Expansion Study

    Excerpt:
    Adult patients were treated with escalating dosages of BGJ398 5 to 150 mg once daily or 50 mg twice daily continuously in 28-day cycles...The DCR in eight patients with FGFR3-mutated bladder/urothelial cancer treated at doses ≥ 100 mg was 75%; three patients (37.5%) achieved PRs (125 mg continuously [n = 1], 125 mg 3-weeks-on/1-week-off [n = 2]) and three patients had SD...
    DOI:
    10.1200/JCO.2016.67.2048
    Trial ID:
    NCT01004224
    Evidence Level:
    Sensitive: D – Preclinical
    Source:
    Int J Mol Sci
    Title:

    Targeting the Src Pathway Enhances the Efficacy of Selective FGFR Inhibitors in Urothelial Cancers with FGFR3 Alterations

    Published date:
    05/01/2020
    Excerpt:
    CONTRADICTING EVIDENCE: In this study, we demonstrate that cells expressing cancer-associated activating FGFR3 mutants and the FGFR3-TACC3 fusion showed primary resistance to infigratinib in long-term colony formation assays in both NIH-3T3 and urothelial carcinoma models.
    DOI:
    10.3390/ijms21093214