Phase 2
N=260
A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)
UC (Urothelial Cancer)
Bottom Line
View on ClinicalTrials.gov: NCT02872714 ↗Enrolled (actual)
260
Serious AEs
47.3%
Results posted
Mar 2023
Primary outcome: Primary: Objective Response Rate (ORR) in Participants With FGFR3 Mutations or Fusions on a CD Regimen — 17.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- pemigatinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) in Participants With FGFR3 Mutations or Fusions on a CD Regimen |
17.8 | — |
| SECONDARY ORR in Participants With FGFR3 Mutations or Fusions on an ID Regimen |
23.3 | — |
| SECONDARY ORR in Participants With All Other FGF/FGFR Alterations |
6.8 | — |
| SECONDARY ORR in All Participants on an ID or CD Regimen in Combined Cohorts |
18.4; 20.6; 18.1 | — |
| SECONDARY Number of Participants With Any Treatment-emergent Adverse Event (TEAE) |
103; 44; 9; 100; 3 | — |
| SECONDARY Progression-free Survival (PFS) |
4.27; 2.04; 4.04 | — |
| SECONDARY Duration of Response (DOR) |
6.21; 10.02; 6.23 | — |
| SECONDARY Overall Survival |
8.90; 9.13; 6.80 | — |
Summary
The purpose of this study is to evaluate the overall response rate (ORR) of pemigatinib as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harboring FGF/FGFR alterations.
Eligibility Criteria
Inclusion Criteria
- 20 years and older in Japan
- Histologically documented metastatic or surgically unresectable urothelial carcinoma; may include primary site from urethra, ureters, upper tract, renal pelvis, and bladder.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Life expectancy ≥ 12 weeks.
- Radiographically measurable per RECIST v1.1.
- Documented FGF/FGFR alteration and have either 1a) failed at least 1 previous treatment for their metastatic or surgically unresectable urothelial carcinoma (ie, chemotherapy, immunotherapy) or 1b) have not received chemotherapy due to poor ECOG status or 2) have insufficient renal function.
Exclusion Criteria
- Prior receipt of a selective FGFR inhibitor.
- Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug.
- Inability or unwillingness to swallow pemigatinib or significant gastrointestinal disorder(s) that could interfere with the absorption, metabolism, or excretion of pemigatinib.
Data sourced from ClinicalTrials.gov (NCT02872714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.