Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations.

Study Overview

• Status: Terminated
• Conditions: Solid Tumor Malignancy
• Intervention / Treatment: Drug: Pemigatinib

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 2

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 02100
    • The Finsen Centre National Hospital
• France
  • Bordeaux, France, 33000
    • Institut Bergonie
  • Dijon, France, 21079
    • CENTRE GEORGES FRAN�OIS LECLERC
  • Nice, France, 06189
    • Centre Antoine Lacassagne
  • Paris, France, 75010
    • Hospital Saint Louis
  • Paris, France, 75014
    • A.P.H. Paris Hopital Cochin
  • Toulouse, France, 31059
    • Institut Universitaire du Cancer de Toulouse Oncopole
• Germany
  • Cologne, Germany, 50937
    • Universitätsklinikum Köln
  • Freiburg im Breisgau, Germany, 79106
    • University Medical Center Freiburg
  • Hamburg, Germany, 20246
    • University Medical Centre Hamburg-Eppendorf, Centre of Oncology
  • Munich, Germany, 81377
    • University Hospital Grosshadern Munich
  • Tübingen, Germany, 72076
    • Universitaetsklinikum in Tubingen
• Israel
  • Afula, Israel, 18101
    • Ha Emek Medical Center
  • Haifa, Israel, 3525408
    • Rambam Health Care Campus
  • Jerusalem, Israel, 90000
    • Hadassah Hebrew University Medical Center Ein Karem Hadassah
  • Petah Tikva, Israel, 4841492
    • Rabin Medical Center - Beilinson Hospital
  • Ẕerifin, Israel, 7030000
    • Assaf Harofeh Medical Center
• Italy
  • Bologna, Italy, 40138
    • L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA � MALPIGHI
  • Candiolo, Italy, 10060
    • Fondazione Del Piemonte Per L Oncologia Ircc Candiolo
  • Milan, Italy, 20133
    • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Napoli, Italy, 80131
    • Istituto Nazionale Tumori Irccs Fondazione Pascale
  • Roma, Italy, 00144
    • Istituto Nazionale Tumori Regina Elena Irccs
  • Verona, Italy, 37134
    • Centro Ricerche Cliniche Di Verona (Crc)
• Japan
  • Fukuoka, Japan, 811-1395
    • National Hospital Organization Kyushu Cancer Center
  • Ishikawa, Japan, 920-8641
    • Kanazawa University Hospital
  • Kobe, Japan, 650-0017
    • Kobe University Hospital
  • Sendai, Japan, 980-8574
    • Tohoku University Hospital
  • Shinjuku-ku, Japan, 160-8582
    • Keio university hospital
  • Shizuoka, Japan, 411-8777
    • Shizuoka Cancer Center
  • Yokohama, Japan, 241-8515
    • Kanagawa cancer center
• South Korea
  • Goyang-si, South Korea, 10408
    • National Cancer Center
  • Seongnam-si, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, South Korea, 06351
    • Samsung Medical Center
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic I Provincial
  • Barcelona, Spain, 08035
    • Hospital General Universitario Vall D Hebron
  • Madrid, Spain, 28050
    • Centro Integral Oncológico Clara Campal (CIOCC)
  • Málaga, Spain, 29010
    • Hospital Regional Universitario de Malaga
  • Pamplona, Spain, 31008
    • Clinica Universidad de Navarra (CUN)
  • Santander, Spain, 39008
    • Hospital Universitario Marqués de Valdecilla
  • Valencia, Spain, 46026
    • Hospital Universitario Y Politcnico de La Fe
• Switzerland
  • Bern, Switzerland, 03010
    • Inselspital - Universitaetsspital Bern
  • Zurich, Switzerland, 08091
    • Universitatsspital Zurich
• United Kingdom
  • London, United Kingdom, W1G 6AD
    • Sarah Cannon Research Institute
  • London, United Kingdom, W12 0HS
    • Imperial College Healthcare NHS Trust - Hammersmith Hospital
  • London, United Kingdom, NW1 2PG
    • University College London Hospitals (UCLH)
• United States
  • Arizona
    • Goodyear, Arizona, United States, 85338
      • Cancer Treatment Centers of America
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Hospital
    • Tucson, Arizona, United States, 85724
      • The University of Arizona Cancer Center
  • California
    • Orange, California, United States, 92868
      • Chao Family Comprehensive Cancer Center University of California, Irvine
    • Palo Alto, California, United States, 94304
      • Stanford Cancer Center
    • Santa Monica, California, United States, 90404
      • John Wayne Cancer Institute
    • Santa Rosa, California, United States, 95403
      • St. Joseph Heritage Healthcare
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialists & Research Institute
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Jacksonville
    • St. Petersburg, Florida, United States, 33705
      • Florida Cancer Specialists
    • Tallahassee, Florida, United States, 32308
      • Florida Cancer Specialists
    • West Palm Beach, Florida, United States, 33401
      • Florida Cancer Specialists
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Illinois Cancer Specialists
    • Skokie, Illinois, United States, 60076
      • Edward H Kaplan & Associates
    • Urbana, Illinois, United States, 61801
      • Carle Cancer Center
    • Zion, Illinois, United States, 60099
      • Cancer Treatment Centers of America
  • Indiana
    • Lafayette, Indiana, United States, 47904
      • Indiana University Health - Arnett Cancer Care
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas Cancer Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic
  • Maine
    • Lewiston, Maine, United States, 04240
      • Central Maine Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Worcester, Massachusetts, United States, 01655
      • Umass Memorial Medical Center, Inc.
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Comprehensive Cancer Centers of Nevada
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
  • New Jersey
    • Florham Park, New Jersey, United States, 07932
      • Summit Medical Group
  • New York
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Oncology Specialists of Charlotte
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Stephenson Cancer Center
    • Tulsa, Oklahoma, United States, 74133
      • Southwestern Regional Medical Center
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Cancer Institute of Greenville Health System
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The West Clinic Pc
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Lubbock, Texas, United States, 79410
      • Joe Arrington Cancer Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists, PC
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates-Lake Wright
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Cancer Care Alliance
    • Tacoma, Washington, United States, 98405
      • MultiCare Institute for Research & Innovation
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Hospitals Inc
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Carbone Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic or is surgically unresectable.
• Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors). Tumor lesions located in a previously irradiated area or in an area subjected to other loco-regional therapy are considered measureable if progression has been clearly demonstrated in the lesion.
• Documentation of an FGFR1-3 gene mutation or translocation.
• Objective progression after at least 1 prior therapy and no therapy available that is likely to provide clinical benefit. Participants who are intolerant to or decline the approved therapy are eligible only if they have no therapy available that is likely to provide clinical benefit.
• Eastern Cooperative Oncology Group performance status 0 to 2.
• Baseline archival tumor specimen (if less than 24 months from date of screening) or willingness to undergo a pretreatment tumor biopsy to obtain the specimen. Must be a tumor block or approximately 15 unstained slides from biopsy or resection of primary tumor or metastasis.
• Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

• Prior receipt of a selective FGFR inhibitor in the past 6 months.
• Receipt of anticancer medications or investigational drugs for any indication or reason within 28 days before first dose of pemigatinib.
• Cannot be a candidate for potentially curative surgery.
• Current evidence of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination.
• Radiation therapy administered within 2 weeks of enrollment/first dose of study treatment.
• Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).
• Known additional malignancy that is progressing or requires active treatment.
• History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.
• Clinically significant or uncontrolled cardiac disease.
• Active chronic or current infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment within 2 weeks before enrollment (participants with asymptomatic chronic infections on prophylactic treatment are allowed).
• Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (defined as elevated transaminases or cirrhosis; chronic HBV/HCV infection with no cirrhosis and no elevated transaminases is allowed).
• Known HIV infection.
• Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or five half-lives (whichever is longer) before the first dose of study drug/treatment.
• Women who are pregnant or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pemigatinib; Cohort A (Solid tumor malignancies with FGFR1-3 in frame fusions; any FGFR2 rearrangement; FGFR1/3 rearrangement with known partner*). Cohort B (Solid tumor malignancies with known or likely activating mutations (excluding kinase domain) in FGFR1-3) Cohort C (Solid tumor malignancies with FGFR1-3 known activating mutations in kinase domain; FGFR1-3 putatively activating mutations; other FGFR1/3 rearrangements* (not eligible for Cohort A)). *Only FGFR fusions or rearrangements with an intact kinase domain are eligible

Drug: Pemigatinib; Pemigatinib administered orally once daily (QD).; Other Names: INCB054828

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR), Defined as the Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) Based on RECIST v1.1 or RANO, in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements	Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1): CR: disappearance of all target/non-target lesions; no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters; no new lesions; no progression of non-target lesions. Per Response Assessment in Neuro-Oncology (RANO; for participants with primary brain tumors): CR: disappearance of all enhancing lesions; stable/improved non-enhancing lesions; stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable enhancing lesions; no progression of non-measurable disease; stable/improved non-enhancing lesions; stable/improved clinically. Cohort determination was based on FGFR status from a central genomics laboratory. Response data were from an independent centralized radiological review committee per RECIST v1.1 and RANO, and response was confirmed.	up to 483 days
ORR, Defined as the Percentage of Participants With a Best Overall Response of CR or PR Based on RECIST v1.1 or RANO, in Participants With Known or Likely Activating FGFR1-3 Mutations	Per RECIST v1.1: CR: disappearance of all target/non-target lesions; no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters; no new lesions; no progression of non-target lesions. Per RANO (for participants with primary brain tumors): CR: disappearance of all enhancing lesions; stable/improved non-enhancing lesions; stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable enhancing lesions; no progression of non-measurable disease; stable/improved non-enhancing lesions; stable/improved clinically. Cohort determination was based on FGFR status from a central genomics laboratory. Response data were from an independent centralized radiological review committee per RECIST v1.1 and RANO, and response was confirmed.	up to 449 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS) in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations	PFS was defined as the time from the first dose until progressive disease (according to RECIST v1.1 or RANO for participants with primary brain tumors and assessed by an independent centralized radiological review committee) or death (whichever occurred first).	up to 532 days
Duration of Response (DOR), Defined as the First CR or PR Assessment Until Progressive Disease (PD) or Death, in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations	Assessment was by an independent centralized radiological review committee; response was confirmed. Per RECIST v1.1: CR: disappearance of all target (TLs)/non-target lesions (NTLs); no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of TLs, taking as a reference the baseline sum diameters; no new lesions; no progression of NTLs. PD: progression of a TL/NTL or presence of new lesion. Per RANO (participants with primary brain tumors): CR: disappearance of all enhancing lesions (ELs); stable/improved non-enhancing lesions (NELs); stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable ELs; no progression of non-measurable disease; stable/improved NELs; stable/improved clinically. PD: >25% increase in sum of perpendicular diameters of all measurable ELs; significant increase of NELs; new lesions; clear clinical deterioration; failure to return for evaluation due to death/deteriorating condition.	up to 24.90 months
Overall Survival in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations	Overall survival was defined as the time from the first dose of study drug to death of any cause.	up to 532 days
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-related Adverse Event (AE)	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as AEs reported for the first time or the worsening of pre-existing events after the first dose of study treatment. Treatment-related AEs were defined as TEAEs judged as related by the investigator or with a missing causality.	up to 651 days

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Peter Langmuir, MD, Incyte Corporation

Publications and helpful links

General Publications

• Rodon J, Damian S, Furqan M, Garcia-Donas J, Imai H, Italiano A, Spanggaard I, Ueno M, Yokota T, Veronese ML, Oliveira N, Li X, Gilmartin A, Schaffer M, Goyal L. Pemigatinib in previously treated solid tumors with activating FGFR1-FGFR3 alterations: phase 2 FIGHT-207 basket trial. Nat Med. 2024 Jun;30(6):1645-1654. doi: 10.1038/s41591-024-02934-7. Epub 2024 May 6.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2019
• Primary Completion (Actual): March 29, 2022
• Study Completion (Actual): March 29, 2022

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Estimated): November 4, 2025
• Last Update Submitted That Met QC Criteria: October 20, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Fibroblast growth factor receptor (FGFR) inhibitor; FGFR mutations; FGFR translocations; solid tumor malignancy
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Bone Diseases, Developmental; Limb Deformities, Congenital; Synostosis; Dysostoses; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Craniosynostoses; Syndactyly; Acrocephalosyndactylia; pemigatinib
• Other Study ID Numbers: INCB 54828-207; 2018-004768-69 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

• IPD Sharing Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• IPD Sharing Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No