NCT02924376

Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)

Completed Phase 2 Results posted Last updated 14 August 2025

What this trial tests

Phase 2 trial testing Pemigatinib in Cholangiocarcinoma in 147 participants. Completed in 1 February 2022.

Timeline

16 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	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	147
Start date	16 January 2017
Primary completion	1 February 2022
Estimated completion	1 February 2022
Sites	120 locations across France, Italy, Japan, Belgium, Taiwan, United Kingdom, Israel, Germany

Drugs / interventions tested

• Pemigatinib (PEMIGATINIB) — full drug profile →

Conditions studied

• Cholangiocarcinoma — all drugs for Cholangiocarcinoma →

Sponsor

Incyte Corporation — full company profile →

Who can join

18 and older, any sex, with Cholangiocarcinoma. 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 FGFR2 Rearrangements or Fusions Primary · up to 1527 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: FGFR2 Rearrangements or Fusions	37.0	27.94 – 46.86

ORR in Participants FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions Secondary · up to 424 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 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. ORR was based on central genomic

Group	Value	95% CI
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions	0.0	0.0 – 16.84

ORR in All Participants With FGF/FGFR Alterations Secondary · up to 1527 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 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. ORR was based on central genomic

Group	Value	95% CI
Cohort A + Cohort B	31.3	23.35 – 40.04

ORR in Participants Negative for FGF/FGFR Alterations Secondary · up to 143 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 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. ORR was based on central genomic

Group	Value	95% CI
Cohort C: Negative for FGF/FGFR Alterations	0.0	0.0 – 19.51

Progression-free Survival (PFS) Secondary · up to 50.17 months

PFS was defined as the length of time from the first dose of 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: FGFR2 Rearrangements or Fusions	7.03	6.08 – 10.48
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions	2.10	1.18 – 4.86
Cohort C: Negative for FGF/FGFR Alterations	1.51	1.38 – 1.84

Duration of Response (DOR) Secondary · up to 47.11 months

DOR was defined as the time from the first overall response contributing to an objective response (CR or PR) as assessed by an independent centralized radiological review committee 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

Group	Value	95% CI
Cohort A: FGFR2 Rearrangements or Fusions	9.13	6.01 – 14.49

Disease Control Rate (DCR) Secondary · up to 1527 days

DCR was defined as the proportion of participants with an overall response of CR, PR, or stable disease (SD), 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 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. PD: progression of a target or non-target lesion or presenc

Group	Value	95% CI
Cohort A: FGFR2 Rearrangements or Fusions	82.4	73.9 – 89.1
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions	40.0	19.1 – 63.9
Cohort C: Negative for FGF/FGFR Alterations	17.6	3.8 – 43.4

Overall Survival Secondary · up to 51.32 months

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

Group	Value	95% CI
Cohort A: FGFR2 Rearrangements or Fusions	17.48	14.36 – 22.93
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions	6.70	2.10 – 10.55
Cohort C: Negative for FGF/FGFR Alterations	3.98	1.97 – 4.60

Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Secondary · up to 1584 days

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 defined as any adverse event either reported for the first time or the worse

Group	Value	95% CI
Cohort A: FGFR2 Rearrangements or Fusions	108
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions	20
Cohort C: Negative for FGF/FGFR Alterations	17
Other	2

First-order Absorption Rate Constant (ka) of Pemigatinib Secondary · Predose; 1-2 hours post-dose; 4-12 hours post-dose

First-order absorption rate constant is defined as the rate at which a drug enters into the system.

Group	Value	95% CI
All Cohorts	1.29	± 0.827

CL/F of Pemigatinib Secondary · Predose; 1-2 hours post-dose; 4-12 hours post-dose

CL/F is defined as apparent oral clearance.

Group	Value	95% CI
All Cohorts	12.2	± 5.28

Vc/F of Pemigatinib Secondary · Predose; 1-2 hours post-dose; 4-12 hours post-dose

Vc/F is defined as the apparent volume of distribution for the central compartment of pemigatinib.

Group	Value	95% CI
All Cohorts	144	± 55.7

Adverse events — posted to ClinicalTrials.gov

Time frame: up to 1584 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort A: FGFR2 Rearrangements or Fusions

Serious: 46/108 (43%)

Deaths: 76/108

Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions

Serious: 10/20 (50%)

Deaths: 18/20

Cohort C: Negative for FGF/FGFR Alterations

Serious: 12/17 (71%)

Deaths: 15/17

Other

Serious: 0/2 (0%)

Deaths: 2/2

Total

Serious: 68/147 (46%)

Deaths: 111/147

Serious adverse events (81 terms)

Reaction	System	Cohort A: FGFR2 Rearrangem…	Cohort B: FGF/FGFR Alterat…	Cohort C: Negative for FGF…	Other	Total
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—
Cholangitis	Hepatobiliary disorders	—	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—
Cholangitis infective	Infections and infestations	—	—	—	—	—
Failure to thrive	Metabolism and nutrition disorders	—	—	—	—	—
Hypercalcaemia	Metabolism and nutrition disorders	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Bacteraemia	Infections and infestations	—	—	—	—	—
Biliary obstruction	Hepatobiliary disorders	—	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—
Chills	General disorders	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—
Device occlusion	Product Issues	—	—	—	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—
Intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—

Other adverse events (194 terms — click to expand)

Reaction	System	Cohort A: FGFR2 Rearrangem…	Cohort B: FGF/FGFR Alterat…	Cohort C: Negative for FGF…	Other	Total
Hyperphosphataemia	Metabolism and nutrition disorders	—	—	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Dry eye	Eye disorders	—	—	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Hypercalcaemia	Metabolism and nutrition disorders	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—

Most-reported serious reactions: Abdominal pain, Pyrexia, Cholangitis, Pleural effusion, Acute kidney injury, Cholangitis infective, Failure to thrive, Hypercalcaemia.

Data from ClinicalTrials.gov NCT02924376 adverse events section.

Sponsor's own description

The purpose of this study is evaluate the efficacy of pemigatinib in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation who have failed at least 1 previous treatment.

Publications & conference data

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

1. Cholangiocarcinoma - evolving concepts and therapeutic strategies.
   Ilyas SI, Khan SA, Hallemeier CL, Kelley RK, et al · · 2018 · cited 1192× · PMID 28994423 · DOI 10.1038/nrclinonc.2017.157
2. Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study.
   Abou-Alfa GK, Sahai V, Hollebecque A, Vaccaro G, et al · · 2020 · cited 1175× · PMID 32203698 · DOI 10.1016/s1470-2045(20)30109-1
3. Small molecules in targeted cancer therapy: advances, challenges, and future perspectives.
   Zhong L, Li Y, Xiong L, Wang W, et al · · 2021 · cited 1003× · PMID 34054126 · DOI 10.1038/s41392-021-00572-w
4. Angiogenic signaling pathways and anti-angiogenic therapy for cancer.
   Liu ZL, Chen HH, Zheng LL, Sun LP, et al · · 2023 · cited 808× · PMID 37169756 · DOI 10.1038/s41392-023-01460-1
5. New Horizons for Precision Medicine in Biliary Tract Cancers.
   Valle JW, Lamarca A, Goyal L, Barriuso J, et al · · 2017 · cited 475× · PMID 28818953 · DOI 10.1158/2159-8290.cd-17-0245
6. Cancer-associated fibroblasts: from basic science to anticancer therapy.
   Yang D, Liu J, Qian H, Zhuang Q. · · 2023 · cited 389× · PMID 37394578 · DOI 10.1038/s12276-023-01013-0
7. Intrahepatic Cholangiocarcinoma: Continuing Challenges and Translational Advances.
   Sirica AE, Gores GJ, Groopman JD, Selaru FM, et al · · 2019 · cited 233× · PMID 30251463 · DOI 10.1002/hep.30289
8. FIGHT-101, a first-in-human study of potent and selective FGFR 1-3 inhibitor pemigatinib in pan-cancer patients with FGF/FGFR alterations and advanced malignancies.
   Subbiah V, Iannotti NO, Gutierrez M, Smith DC, et al · · 2022 · cited 157× · PMID 35176457 · DOI 10.1016/j.annonc.2022.02.001