Evidence Level:Sensitive: C2 – Inclusion Criteria
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 ]
Evidence Level:Sensitive: C3 – Early Trials
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)
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
Title:
cfDNA is an acceptable but insufficient means of characterizing FGFR3 mutation in patients with metastatic urothelial cancer (mUC)
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
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
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
Evidence Level:Sensitive: D – Preclinical
Title:
Targeting the Src Pathway Enhances the Efficacy of Selective FGFR Inhibitors in Urothelial Cancers with FGFR3 Alterations
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.