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An open-label study of pemigatinib in cholangiocarcinoma: final results from FIGHT-202
A Vogel1, V Sahai2, A Hollebecque3
1Hannover Medical School, Hannover, Germany; Toronto General Hospital, Toronto; Princess Margaret Cancer Centre, Toronto, Canada.
Background:
Fibroblast growth factor receptor 2 (FGFR2) fusions and rearrangements are clinically actionable genomic alterations in cholangiocarcinoma (CCA). Pemigatinib is a selective, potent, oral inhibitor of FGFR1-3 and demonstrated efficacy in patients with previously treated, advanced/metastatic CCA with FGFR2 alterations in FIGHT-202 (NCT02924376). We report final outcomes from the extended follow-up period.
Patients And Methods:
The multicenter, open-label, single-arm, phase II FIGHT-202 study enrolled patients ≥18 years old with previously treated advanced/metastatic CCA with FGFR2 fusions or rearrangements (cohort A), other FGF/FGFR alterations (cohort B), or no FGF/FGFR alterations (cohort C). Patients received once-daily oral pemigatinib 13.5 mg in 21-day cycles (2 weeks on, 1 week off) until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) in cohort A assessed as per RECIST v1.1 by an independent review committee; secondary endpoints included duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.
Results:
FIGHT-202 enrolled 147 patients (cohort A, 108; cohort B, 20; cohort C, 17; unconfirmed FGF/FGFR alterations, 2). By final analysis, 145 (98.6%) had discontinued treatment due to progressive disease (71.4%), withdrawal by patient (8.2%), or adverse events (AEs; 6.8%). Median follow-up was 45.4 months. The ORR in cohort A was 37.0% (95% confidence interval 27.9% to 46.9%); complete and partial responses were observed in 3 and 37 patients, respectively. Median DOR was 9.1 (6.0-14.5) months; median PFS and OS were 7.0 (6.1-10.5) months and 17.5 (14.4-22.9) months, respectively. The most common treatment-emergent AEs (TEAEs) were hyperphosphatemia (58.5%), alopecia (49.7%), and diarrhea (47.6%). Overall, 15 (10.2%) patients experienced TEAEs leading to pemigatinib discontinuation; intestinal obstruction and acute kidney injury (n = 2 each) occurred most frequently.
Conclusions:
Pemigatinib demonstrated durable response and prolonged OS with manageable AEs in patients with previously treated, advanced/metastatic CCA with FGFR2 alterations in the extended follow-up period of FIGHT-202.
Insights
Pemigatinib showed durable responses and extended overall survival in advanced cholangiocarcinoma patients with FGFR2 alterations. This targeted therapy offers a manageable safety profile for previously treated individuals.
Area of Science:
- Oncology
- Genomics
- Pharmacology
Background:
- Fibroblast growth factor receptor 2 (FGFR2) alterations are key drivers in cholangiocarcinoma (CCA).
- Pemigatinib, an FGFR inhibitor, previously showed efficacy in advanced CCA with FGFR2 alterations.
- This study reports extended follow-up outcomes for pemigatinib in CCA patients.
Purpose of the Study:
- To evaluate the final efficacy and safety outcomes of pemigatinib in advanced/metastatic CCA.
- To assess long-term response, progression-free survival (PFS), and overall survival (OS) in patients with FGFR2 alterations.
- To analyze treatment-emergent adverse events (TEAEs) in the extended follow-up period.
Main Methods:
- Phase II, multicenter, open-label, single-arm study (FIGHT-202).
- Patients with previously treated advanced/metastatic CCA and FGFR2 alterations received oral pemigatinib (13.5 mg daily).
- Primary endpoint: objective response rate (ORR); secondary endpoints: duration of response (DOR), PFS, OS, and safety.
Main Results:
- The ORR in cohort A (FGFR2 alterations) was 37.0%, with a median DOR of 9.1 months.
- Median PFS was 7.0 months and median OS was 17.5 months.
- Common TEAEs included hyperphosphatemia (58.5%) and alopecia (49.7%); 10.2% of patients discontinued due to TEAEs.
Conclusions:
- Pemigatinib provides durable responses and prolongs OS in advanced CCA patients with FGFR2 alterations.
- The safety profile of pemigatinib is manageable in this patient population.
- Extended follow-up confirms pemigatinib's role in treating CCA with specific genomic alterations.
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