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Bending the Curve Trial by Trial
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FIGHT-202

Needs review

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Translocations Who Failed Previous Therapy (FIGHT-202)

Phase 2N = 146NCT02924376

Population
Adults with previously treated (progression after at least one previous treatment), locally advanced or metastatic cholangiocarcinoma and ECOG performance status 0-2, grouped by FGF/FGFR alteration status; efficacy results below are for cohort A (FGFR2 fusions or rearrangements).
Design
Multicentre, open-label, single-arm, multicohort phase 2 study of pemigatinib 13.5 mg orally once daily (21-day cycles, 2 weeks on and 1 week off) until progression, unacceptable toxicity, withdrawal of consent or physician decision. Patients were assigned to cohort A (FGFR2 fusions or rearrangements), cohort B (other FGF/FGFR alterations) or cohort C (no FGF/FGFR alterations). Primary endpoint: objective response in cohort A, assessed centrally. The 2020 report enrolled 146 patients (107 in cohort A); the final analysis and the registry give 147 (108 in cohort A). Single-arm; no comparison group.
Primary endpoint
ORR
Arms
  • Pemigatinib (experimental, n = 146): Pemigatinib 13.5 mg orally once daily, 2 weeks on and 1 week off in 21-day cycles
People
Abou-Alfa GK
Show the numbers
Results reported for FIGHT-202
EndpointAnalysisPemigatinibControlEffect
ORRCohort A: FGFR2 fusion or rearrangement (107)Objective response (complete or partial) assessed centrally in patients with FGFR2 fusions or rearrangements (cohort A) who received at least one doseprimaryAbou-Alfa 202035.5% (26.5–45.4%)—38 of 107 patients responded (three complete and 35 partial responses). Median follow-up for the whole study was 17.8 months (IQR 11.6-21.3). The paper has a published correction (Lancet Oncol 2024;25:e3) whose content could not be checked against these figures; the later final analysis (108 patients in cohort A) is recorded as separate results.
ORRCohort A: FGFR2 fusion or rearrangement (108)finalmedian follow-up 45.4 monthsVogel 202437% (27.9–46.9%)—Assessed by an independent review committee per RECIST v1.1; three complete and 37 partial responses. Final analysis from the extended follow-up period; 147 patients enrolled overall.
DORCohort A: FGFR2 fusion or rearrangement (108)finalVogel 2024median 9.1 months (6.0–14.5)——
PFSCohort A: FGFR2 fusion or rearrangement (108)finalVogel 2024median 7 months (6.1–10.5)—Single-arm study: median progression-free survival is descriptive, not a comparison.
OSCohort A: FGFR2 fusion or rearrangement (108)finalVogel 2024median 17.5 months (14.4–22.9)——
Results reported for FIGHT-202
EndpointAnalysisPemigatinibControlEffect
ORRCohort A: FGFR2 fusion or rearrangement (107)Objective response (complete or partial) assessed centrally in patients with FGFR2 fusions or rearrangements (cohort A) who received at least one doseprimaryAbou-Alfa 202035.5% (26.5–45.4%)—38 of 107 patients responded (three complete and 35 partial responses). Median follow-up for the whole study was 17.8 months (IQR 11.6-21.3). The paper has a published correction (Lancet Oncol 2024;25:e3) whose content could not be checked against these figures; the later final analysis (108 patients in cohort A) is recorded as separate results.
ORRCohort A: FGFR2 fusion or rearrangement (108)finalmedian follow-up 45.4 monthsVogel 202437% (27.9–46.9%)—Assessed by an independent review committee per RECIST v1.1; three complete and 37 partial responses. Final analysis from the extended follow-up period; 147 patients enrolled overall.
DORCohort A: FGFR2 fusion or rearrangement (108)finalVogel 2024median 9.1 months (6.0–14.5)——
PFSCohort A: FGFR2 fusion or rearrangement (108)finalVogel 2024median 7 months (6.1–10.5)—Single-arm study: median progression-free survival is descriptive, not a comparison.
OSCohort A: FGFR2 fusion or rearrangement (108)finalVogel 2024median 17.5 months (14.4–22.9)——
Illustrative — modelled from reported values, not trial data. DOR, final.
0%25%50%75%100%05101520Months (modelled)
  • Pemigatinib (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsPemigatinib
0100.0%
663.3%
1143.3%
1727.4%
2317.3%
Illustrative — modelled from reported values, not trial data. PFS, final.
0%25%50%75%100%051015Months (modelled)
  • Pemigatinib (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsPemigatinib
0100.0%
467.3%
941.0%
1327.6%
1816.8%
Primary publication: Abou-Alfa GK, Sahai V, Hollebecque A, Vaccaro G, Melisi D, Al-Rajabi R, et al. Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study. Lancet Oncol. 2020;21(5):671-684. PubMedDOI

Appears in

Sources

  1. Abou-Alfa GK, Sahai V, Hollebecque A, Vaccaro G, Melisi D, Al-Rajabi R, et al. Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study. Lancet Oncol. 2020;21(5):671-684.

    PubMedDOI

  2. Vogel A, Sahai V, Hollebecque A, Vaccaro GM, Melisi D, Al Rajabi RM, et al. An open-label study of pemigatinib in cholangiocarcinoma: final results from FIGHT-202. ESMO Open. 2024;9(6):103488.

    PubMedDOI