Phase 2
N=47
A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)
MPN (Myeloproliferative Neoplasms)
Bottom Line
View on ClinicalTrials.gov: NCT03011372 ↗Enrolled (actual)
47
Serious AEs
57.5%
Results posted
Nov 2025
Primary outcome: Primary: Percentage of Participants Who Achieved Complete Response (CR) as Determined by Investigator Assessment According to the Response Criteria for Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement — 68.9 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
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Complete Response (CR) as Determined by Investigator Assessment According to the Response Criteria for Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement |
68.9 | — |
| SECONDARY Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) as Determined by Investigator Assessment According to the Response Criteria for Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement |
77.8 | — |
| SECONDARY Percentage of Participants Who Achieved a Complete Cytogenetic Response (CCyR) as Assessed by Local Analysis and Investigator Evaluation |
73.3 | — |
| SECONDARY Percentage of Participants Who Achieved a Partial Cytogenetic Response (PCyR) as Assessed by Local Analysis and Investigator Evaluation |
8.9 | — |
| SECONDARY Percentage of Participants Who Achieved a PCyR as Assessed by CRC Assessment |
15.6 | — |
| SECONDARY Duration of Complete Response |
53.29; NA | — |
| SECONDARY Duration of Response |
53.29; NA | — |
| SECONDARY Progression-free Survival (PFS) |
73.89; 73.89 | — |
| SECONDARY Overall Survival |
NA | — |
| SECONDARY Number of Participants With Any Treatment-emergent Adverse Event (TEAE) |
47 | — |
| SECONDARY Number of Participants With Any ≥Grade 3 TEAE |
39 | — |
Summary
The purpose of this study is to evaluate the efficacy and safety of pemigatinib (INCB054828) in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1 rearrangement.
Eligibility Criteria
Inclusion Criteria
- Documented lymphoid or myeloid neoplasm with 8p11 rearrangement known to lead to FGFR1 activation, based on standard diagnostic cytogenetic evaluation performed locally, before signing informed consent for this study.
- Eligible subjects must:
- Have relapsed after stem cell transplantation or after other disease modifying therapy, OR
- Not be current candidates for stem cell transplantation or other disease modifying therapies.
- Note: All relapsed/refractory subjects must have evidence of either cytogenetic or hematological disease and have no evidence of residual toxicity (eg, graft-versus-host disease requiring treatment).
- Life expectancy ≥ 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
Exclusion Criteria
- Prior receipt of a selective FGFR inhibitor.
- History and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, except calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.
- Current evidence of corneal disorder/keratopathy, including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis, as confirmed by ophthalmologic examination.
- Use of any potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug.
Data sourced from ClinicalTrials.gov (NCT03011372). 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.