^
Association details:
| Biomarker: | FGFR3 mutation |
|---|---|
| Cancer: | Urothelial Cancer |
| Drug: | Pemazyre (pemigatinib) (FGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors
Excerpt:
...Characterize the safety profile of pemigatinib therapy`Number of Participants with Complete Response and FGFR3 Mutational Status`Number of Participants with Non-Muscle Invasive Bladder Cancer (NMIBC) and Complete Response`Maximal concentration (Cmax, nmol/L) of pemigatinib in urothelial tissue at post-treatment TURBT`Relapse Free Survival (RFS) at 6 months`Relapse Free Survival (RFS) at 12 months`Relapse Free Survival (RFS) at 24 months...
Source:
Title:
A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)
Excerpt:
...ORR in Participants With FGFR3 Mutations or Fusions on an ID Regimen`ORR in Participants With All Other FGF/FGFR Alterations`ORR in All Participants on an ID or CD Regimen in Combined Cohorts`Number of Participants With Any Treatment-emergent Adverse Event (TEAE)`Progression-free Survival (PFS)`Duration of Response (DOR)`Overall Survival...
Trial ID:
More C2 evidence
Source:
Title:
Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205)
Excerpt:
...- Known FGFR3 mutation or rearrangement confirmed by the central laboratory prior to randomization....
Trial ID:
Source:
Title:
A Phase 2, Open-Label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Plus Pembrolizumab Versus Pemigatinib Alone Versus Standard of Care as First-Line Treatment for Metastatic or Unresectable Urothelial Carcinoma in Cisplatin-Ineligible Participants Whose Tumors Express FGFR3 Mutation or Rearrangement (FIGHT-205)
Excerpt:
...Must have known FGFR3 mutation or rearrangement (participant can be randomized based on a local report, but this will need to be retrospectively confirmed by the sponsor's central laboratory; see Appendix E). ...
Trial ID:
Less C2 evidence
Source:
Title:
Pemigatinib for Metastatic or Surgically Unresectable Urothelial Carcinoma With FGF/FGFR Genomic Alterations: Final Results From FIGHT-201
Published date:
11/14/2023
Excerpt:
Pemigatinib was generally well tolerated and demonstrated clinical activity in previously treated, unresectable or metastatic UC with FGFR3 mutations or fusions/rearrangements.
DOI:
10.1016/j.annonc.2023.10.794
Trial ID:
Source:
Title:
Interim results of fight-201, a phase II, open-label, multicenter study of INCB054828 in patients (pts) with metastatic or surgically unresectable urothelial carcinoma (UC) harboring fibroblast growth factor (FGF)/FGF receptor (FGFR) genetic alterations (GA)
Excerpt:
This study (NCT02872714) is enrolling pts with metastatic or unresectable UC who failed ≥ 1 therapy or are platinum ineligible and have FGFR3 mutations/fusions (cohort A, n = 100) or other FGF/FGFR GAs (cohort B, n = 40)....Best overall responses in cohort A were 7 confirmed partial responses (PRs), 6 unconfirmed PRs (ongoing), and 17 stable disease (10 ongoing). ORR, including unconfirmed PRs, was 25% (95% CI, 14%–40%).
DOI:
https://doi.org/10.1093/annonc/mdy283.109
Trial ID:
