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)

NCT03822117 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: INCB 54828-2072018-004768-69
• Study Type: interventional
• Target: 111
• Locations: 11 countries
• Sites: 90

Brief Summary

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.

Conditions

Solid Tumor Malignancy

Keywords

Fibroblast growth factor receptor (FGFR) inhibitor; FGFR mutations; FGFR translocations; solid tumor malignancy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

  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

  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

  up to 532 days

• Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-related Adverse Event (AE)

  up to 651 days

Study Arms (1)

Pemigatinib

EXPERIMENTAL

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

Interventions

Pemigatinib DRUG

Pemigatinib administered orally once daily (QD).

Also known as: INCB054828

Pemigatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (90)

Cancer Treatment Centers of America

Goodyear, Arizona, 85338, United States

Location

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

The University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, 92868, United States

Location

Stanford Cancer Center

Palo Alto, California, 94304, United States

Location

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

St. Joseph Heritage Healthcare

Santa Rosa, California, 95403, United States

Location

Florida Cancer Specialists & Research Institute

Fort Myers, Florida, 33901, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Florida Cancer Specialists

St. Petersburg, Florida, 33705, United States

Location

Florida Cancer Specialists

Tallahassee, Florida, 32308, United States

Location

Florida Cancer Specialists

West Palm Beach, Florida, 33401, United States

Location

Illinois Cancer Specialists

Arlington Heights, Illinois, 60005, United States

Location

Edward H Kaplan & Associates

Skokie, Illinois, 60076, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Cancer Treatment Centers of America

Zion, Illinois, 60099, United States

Location

Indiana University Health - Arnett Cancer Care

Lafayette, Indiana, 47904, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Location

Ochsner Clinic

New Orleans, Louisiana, 70121, United States

Location

Central Maine Medical Center

Lewiston, Maine, 04240, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Umass Memorial Medical Center, Inc.

Worcester, Massachusetts, 01655, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89148, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Summit Medical Group

Florham Park, New Jersey, 07932, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Oncology Specialists of Charlotte

Charlotte, North Carolina, 28204, United States

Location

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Southwestern Regional Medical Center

Tulsa, Oklahoma, 74133, United States

Location

Cancer Institute of Greenville Health System

Greenville, South Carolina, 29605, United States

Location

The West Clinic Pc

Germantown, Tennessee, 38138, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Joe Arrington Cancer Center

Lubbock, Texas, 79410, United States

Location

Virginia Cancer Specialists, Pc

Fairfax, Virginia, 22031, United States

Location

Virginia Oncology Associates-Lake Wright

Norfolk, Virginia, 23502, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Multicare Institute For Research & Innovation

Tacoma, Washington, 98405, United States

Location

West Virginia University Hospitals Inc

Morgantown, West Virginia, 26506, United States

Location

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

The Finsen Centre National Hospital

Copenhagen, 02100, Denmark

Location

Institut Bergonie

Bordeaux, 33000, France

Location

CENTRE GEORGES FRAN�OIS LECLERC

Dijon, 21079, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hospital Saint Louis

Paris, 75010, France

Location

A.P.H. Paris Hopital Cochin

Paris, 75014, France

Location

Institut Universitaire Du Cancer de Toulouse Oncopole

Toulouse, 31059, France

Location

Universitatsklinikum Koln

Cologne, 50937, Germany

Location

University Medical Center Freiburg

Freiburg im Breisgau, 79106, Germany

Location

University Medical Centre Hamburg-Eppendorf, Centre of Oncology

Hamburg, 20246, Germany

Location

University Hospital Grosshadern Munich

Munich, 81377, Germany

Location

Universitaetsklinikum in Tubingen

Tübingen, 72076, Germany

Location

Ha Emek Medical Center

Afula, 18101, Israel

Location

Rambam Health Care Campus

Haifa, 3525408, Israel

Location

Hadassah Hebrew University Medical Center Ein Karem Hadassah

Jerusalem, 90000, Israel

Location

Rabin Medical Center - Beilinson Hospital

Petah Tikva, 4841492, Israel

Location

Assaf Harofeh Medical Center

Ẕerifin, 7030000, Israel

Location

L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA � MALPIGHI

Bologna, 40138, Italy

Location

Fondazione Del Piemonte Per L Oncologia Ircc Candiolo

Candiolo, 10060, Italy

Location

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, 20133, Italy

Location

Istituto Nazionale Tumori Irccs Fondazione Pascale

Napoli, 80131, Italy

Location

Istituto Nazionale Tumori Regina Elena Irccs

Roma, 00144, Italy

Location

Centro Ricerche Cliniche Di Verona (Crc)

Verona, 37134, Italy

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

Kanazawa University Hospital

Ishikawa, 920-8641, Japan

Location

Kobe University Hospital

Kobe, 650-0017, Japan

Location

Tohoku University Hospital

Sendai, 980-8574, Japan

Location

Keio University Hospital

Shinjuku-ku, 160-8582, Japan

Location

Shizuoka Cancer Center

Shizuoka, 411-8777, Japan

Location

Kanagawa Cancer Center

Yokohama, 241-8515, Japan

Location

National Cancer Center

Goyang-si, 10408, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hospital General Universitario Vall D Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic I Provincial

Barcelona, 08036, Spain

Location

Centro Integral Oncologico Clara Campal (Ciocc)

Madrid, 28050, Spain

Location

Hospital Regional Universitario de Malaga

Málaga, 29010, Spain

Location

Clinica Universidad de Navarra (Cun)

Pamplona, 31008, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Hospital Universitario Y Politcnico de La Fe

Valencia, 46026, Spain

Location

Inselspital - Universitaetsspital Bern

Bern, 03010, Switzerland

Location

Universitatsspital Zurich

Zurich, 08091, Switzerland

Location

University College London Hospitals (Uclh)

London, NW1 2PG, United Kingdom

Location

Imperial College Healthcare Nhs Trust - Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

Sarah Cannon Research Institute

London, W1G 6AD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 38710951 DERIVED

MeSH Terms

Conditions

Acrocephalosyndactylia

Interventions

pemigatinib

Condition Hierarchy (Ancestors)

Craniosynostoses; Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Syndactyly; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Peter Langmuir, MD

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Model Details: This study consists of 3 cohorts that will have study drug administered in parallel, Cohort A, Cohort B, and Cohort C. There is no difference in the treatment regimen between the cohorts.

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: January 30, 2019
• Study Start: October 17, 2019
• Primary Completion: March 29, 2022
• Study Completion: March 29, 2022
• Last Updated: November 4, 2025
• Results First Posted: March 15, 2023

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• 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.

Locations

CH (2); JP (7); DE (5); IL (5); IT (6); FR (6); DK (1); GB (3); US (44); KR (4); ES (7)