NCT02872714

A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)

Completed Phase 2 Results posted Last updated 14 August 2025

What this trial tests

Phase 2 trial testing pemigatinib in UC (Urothelial Cancer) in 263 participants. Completed in 1 February 2022.

Timeline

12 January 2017

Primary endpoint
1 February 2022

1 February 2022

Quick facts

Lead sponsor	Incyte Corporation
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	263
Start date	12 January 2017
Primary completion	1 February 2022
Estimated completion	1 February 2022
Sites	96 locations across Denmark, France, Italy, Japan, Netherlands, Belgium, United Kingdom, Germany

Drugs / interventions tested

• pemigatinib (PEMIGATINIB) — full drug profile →
• pemigatinib (PEMIGATINIB) — full drug profile →

Conditions studied

• UC (Urothelial Cancer) — all drugs for UC (Urothelial Cancer) →

Sponsor

Incyte Corporation — full company profile →

Who can join

18 and older, any sex, with UC (Urothelial Cancer). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Objective Response Rate (ORR) in Participants With FGFR3 Mutations or Fusions on a CD Regimen Primary · up to 1138 days

ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) at any post-Baseline visit prior to first progressive disease (PD), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taki

Group	Value	95% CI
Cohort A-CD: FGFR3 Mutations or Fusions	17.8	10.92 – 26.70

ORR in Participants With FGFR3 Mutations or Fusions on an ID Regimen Secondary · up to 817 days

ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based

Group	Value	95% CI
Cohort A-ID: FGFR3 Mutations or Fusions	23.3	15.54 – 32.66

ORR in Participants With All Other FGF/FGFR Alterations Secondary · up to 1198 days

ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based

Group	Value	95% CI
Cohort B-ID: All Other FGF/FGFR Alterations	6.8	1.43 – 18.66

ORR in All Participants on an ID or CD Regimen in Combined Cohorts Secondary · up to 1198 days

ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based

Group	Value	95% CI
Cohort A-ID + Cohort B-ID	18.4	12.47 – 25.59
Cohort A-ID + Cohort A-CD	20.6	15.26 – 26.79
Cohort A-ID + Cohort B-ID + Cohort A-CD	18.1	13.55 – 23.52

Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Secondary · up to approximately 25 weeks

An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was any AE either reported for the first time or the worsening of a pre-existing

Group	Value	95% CI
Cohort A-ID: FGFR3 Mutations or Fusions	103
Cohort B-ID: All Other FGF/FGFR Alterations	44
Other-ID	9
Cohort A-CD: FGFR3 Mutations or Fusions	100
Other-CD	3

Progression-free Survival (PFS) Secondary · up to 1138 days

PFS was defined as the length of time from the start of the study drug (Day 1) to the earlier of death or disease progression by RECIST v1.1, as assessed by the independent centralized radiological review committee.

Group	Value	95% CI
Cohort A-ID: FGFR3 Mutations or Fusions	4.27	3.91 – 6.05
Cohort B-ID: All Other FGF/FGFR Alterations	2.04	1.87 – 2.17
Cohort A-CD: FGFR3 Mutations or Fusions	4.04	3.45 – 4.17

Duration of Response (DOR) Secondary · up to 1075 days

DOR was defined as the time from the first overall response contributing to an objective response (CR or PR) to the earlier of death or first overall response of PD occurring after the first overall response contributing to the objective response. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseli

Group	Value	95% CI
Cohort A-ID: FGFR3 Mutations or Fusions	6.21	4.60 – 7.95
Cohort B-ID: All Other FGF/FGFR Alterations	10.02	8.38 – NA
Cohort A-CD: FGFR3 Mutations or Fusions	6.23	4.14 – 8.25

Overall Survival Secondary · up to 1610 days

Overall survival was defined as the length of time from the start of the study drug (Day 1) until the date of death due to any cause.

Group	Value	95% CI
Cohort A-ID: FGFR3 Mutations or Fusions	8.90	7.46 – 15.18
Cohort B-ID: All Other FGF/FGFR Alterations	9.13	5.52 – 17.05
Cohort A-CD: FGFR3 Mutations or Fusions	6.80	5.26 – 9.10

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort A-ID: FGFR3 Mutations or Fusions

Serious: 45/103 (44%)

Deaths: 88/103

Cohort B-ID: All Other FGF/FGFR Alterations

Serious: 26/44 (59%)

Deaths: 39/44

Other-ID

Serious: 3/9 (33%)

Deaths: 8/9

Cohort A-CD: FGFR3 Mutations or Fusions

Serious: 48/101 (48%)

Deaths: 83/101

Other-CD

Serious: 1/3 (33%)

Deaths: 2/3

Serious adverse events (139 terms)

Reaction	System	Cohort A-ID: FGFR3 Mutatio…	Cohort B-ID: All Other FGF…	Other-ID	Cohort A-CD: FGFR3 Mutatio…	Other-CD
Urinary tract infection	Infections and infestations	—	—	—	—	—
General physical health deterioration	General disorders	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—
Haematuria	Renal and urinary disorders	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Renal failure	Renal and urinary disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Device related infection	Infections and infestations	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Disease progression	General disorders	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Hydronephrosis	Renal and urinary disorders	—	—	—	—	—
Hypercalcaemia	Metabolism and nutrition disorders	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—
Pain	General disorders	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—
Spinal cord compression	Nervous system disorders	—	—	—	—	—
Subileus	Gastrointestinal disorders	—	—	—	—	—
Urosepsis	Infections and infestations	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—

Other adverse events (137 terms — click to expand)

Reaction	System	Cohort A-ID: FGFR3 Mutatio…	Cohort B-ID: All Other FGF…	Other-ID	Cohort A-CD: FGFR3 Mutatio…	Other-CD
Hyperphosphataemia	Metabolism and nutrition disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—	—	—
Dry eye	Eye disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—
Blood phosphorus increased	Investigations	—	—	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Haematuria	Renal and urinary disorders	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—
Hypercalcaemia	Metabolism and nutrition disorders	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—
Nail discolouration	Skin and subcutaneous tissue disorders	—	—	—	—	—
Nail disorder	Skin and subcutaneous tissue disorders	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—
Onycholysis	Skin and subcutaneous tissue disorders	—	—	—	—	—
Visual acuity reduced	Eye disorders	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—

Most-reported serious reactions: Urinary tract infection, General physical health deterioration, Acute kidney injury, Haematuria, Constipation, Nausea, Renal failure, Abdominal pain.

Data from ClinicalTrials.gov NCT02872714 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cancer-associated fibroblasts and resistance to anticancer therapies: status, mechanisms, and countermeasures.
   Feng B, Wu J, Shen B, Jiang F, et al · · 2022 · cited 150× · PMID 35488263 · DOI 10.1186/s12935-022-02599-7
2. INCB054828 (pemigatinib), a potent and selective inhibitor of fibroblast growth factor receptors 1, 2, and 3, displays activity against genetically defined tumor models.
   Liu PCC, Koblish H, Wu L, Bowman K, et al · · 2020 · cited 124× · PMID 32315352 · DOI 10.1371/journal.pone.0231877
3. FGFR-TKI resistance in cancer: current status and perspectives.
   Yue S, Li Y, Chen X, Wang J, et al · · 2021 · cited 98× · PMID 33568192 · DOI 10.1186/s13045-021-01040-2
4. Facts and New Hopes on Selective FGFR Inhibitors in Solid Tumors.
   Facchinetti F, Hollebecque A, Bahleda R, Loriot Y, et al · · 2020 · cited 91× · PMID 31585937 · DOI 10.1158/1078-0432.ccr-19-2035
5. FGFR Fusions in Cancer: From Diagnostic Approaches to Therapeutic Intervention.
   De Luca A, Esposito Abate R, Rachiglio AM, Maiello MR, et al · · 2020 · cited 87× · PMID 32962091 · DOI 10.3390/ijms21186856
6. Structure, activation and dysregulation of fibroblast growth factor receptor kinases: perspectives for clinical targeting.
   Farrell B, Breeze AL. · · 2018 · cited 77× · PMID 30545934 · DOI 10.1042/bst20180004
7. Current Strategies and Novel Therapeutic Approaches for Metastatic Urothelial Carcinoma.
   Mollica V, Rizzo A, Montironi R, Cheng L, et al · · 2020 · cited 75× · PMID 32498352 · DOI 10.3390/cancers12061449
8. FGFR4: A promising therapeutic target for breast cancer and other solid tumors.
   Levine KM, Ding K, Chen L, Oesterreich S. · · 2020 · cited 68× · PMID 32492514 · DOI 10.1016/j.pharmthera.2020.107590