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FOENIX-CCA2

Futibatinib for FGFR2-Rearranged Intrahepatic Cholangiocarcinoma (FOENIX-CCA2)

Phase 2N = 103NCT02052778

Population
Patients with unresectable or metastatic FGFR2 fusion- or rearrangement-positive intrahepatic cholangiocarcinoma and disease progression after one or more previous lines of systemic therapy (FGFR inhibitors excluded).
Design
Multinational, open-label, single-group phase 2 study of futibatinib 20 mg orally once daily (continuous) in unresectable or metastatic FGFR2 fusion- or rearrangement-positive intrahepatic cholangiocarcinoma with progression after one or more previous lines of systemic therapy (excluding FGFR inhibitors). Primary endpoint: objective response by independent central review. The registry record NCT02052778 is a phase 1/2 study of TAS-120 in solid tumours with 407 patients enrolled across all cohorts; this record uses the 103 patients of the paper. Single-arm; no comparison group.
Primary endpoint
ORR
Arms
  • Futibatinib (experimental, n = 103): Futibatinib 20 mg orally once daily, continuous
People
Goyal L
Show the numbers
Results reported for FOENIX-CCA2
EndpointAnalysisFutibatinibControlEffect
ORRAll enrolled patients who received futibatinib (103)Objective response (partial or complete) assessed by independent central reviewprimaryGoyal 202342% (32–52%)—43 of 103 patients responded.
DORResponders among 103 patientsprimaryGoyal 2023median 9.7 months——
PFSAll enrolled patients who received futibatinib (103)primarymedian follow-up 17.1 monthsGoyal 2023median 9 months—Single-arm study: median progression-free survival is descriptive, not a comparison.
OSAll enrolled patients who received futibatinib (103)primarymedian follow-up 17.1 monthsGoyal 2023median 21.7 months——
Results reported for FOENIX-CCA2
EndpointAnalysisFutibatinibControlEffect
ORRAll enrolled patients who received futibatinib (103)Objective response (partial or complete) assessed by independent central reviewprimaryGoyal 202342% (32–52%)—43 of 103 patients responded.
DORResponders among 103 patientsprimaryGoyal 2023median 9.7 months——
PFSAll enrolled patients who received futibatinib (103)primarymedian follow-up 17.1 monthsGoyal 2023median 9 months—Single-arm study: median progression-free survival is descriptive, not a comparison.
OSAll enrolled patients who received futibatinib (103)primarymedian follow-up 17.1 monthsGoyal 2023median 21.7 months——
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%05101520Months (modelled)
  • Futibatinib (experimental)

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

Data table (modelled values)
MonthsFutibatinib
0100.0%
665.1%
1242.4%
1827.6%
2418.0%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Futibatinib (experimental)

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

Data table (modelled values)
MonthsFutibatinib
0100.0%
663.0%
1142.9%
1727.0%
2317.0%
Primary publication: Goyal L, Meric-Bernstam F, Hollebecque A, Valle JW, Morizane C, Karasic TB, et al. Futibatinib for FGFR2-Rearranged Intrahepatic Cholangiocarcinoma. N Engl J Med. 2023;388(3):228-239. PubMedDOI

Appears in

Sources

  1. Goyal L, Meric-Bernstam F, Hollebecque A, Valle JW, Morizane C, Karasic TB, et al. Futibatinib for FGFR2-Rearranged Intrahepatic Cholangiocarcinoma. N Engl J Med. 2023;388(3):228-239.

    PubMedDOI