Futibatinib for <i>FGFR2</i> -Rearranged Intrahepatic Cholangiocarcinoma

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  • Lipika Goyal
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Funda Meric-Bernstam
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Antoine Hollebecque
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Juan W. Valle
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Chigusa Morizane
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Thomas B. Karasic
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Thomas A. Abrams
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Junji Furuse
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Robin K. Kelley
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Philippe A. Cassier
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Heinz-Josef Klümpen
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Heung-Moon Chang
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Li-Tzong Chen
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Josep Tabernero
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Do-Youn Oh
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Amit Mahipal
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Markus Moehler
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Edith P. Mitchell
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Yoshito Komatsu
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Kunihiro Masuda
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Daniel Ahn
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Robert S. Epstein
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Abdel-Baset Halim
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Yao Fu
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Tehseen Salimi
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Volker Wacheck
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Yaohua He
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Mei Liu
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • Karim A. Benhadji
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...
  • John A. Bridgewater
    From the Department of Medicine, Stanford University School of Medicine, and the Stanford Cancer Center, Palo Alto (L.G.), and the University of California, San Francisco, San Francisco (R.K.K.) — both in California; the Mass General Cancer Center, Harvard Medical School (L.G.), and Dana–Farber Cancer Institute (T.A.A.) — both in Boston; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B.); the Drug Development Department, Gustave Roussy, Villejuif (A.H.), and Centre Léon Bérard,...

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Background: Alterations in fibroblast growth factor receptor 2 (FGFR2) have emerged as promising drug targets for intrahepatic cholangiocarcinoma, a rare cancer with a poor prognosis. Futibatinib, a next-generation, covalently binding FGFR1-4 inhibitor, has been shown to have both antitumor activity in patients with FGFR-altered tumors and strong preclinical activity against acquired resistance mutations associated with ATP-competitive FGFR inhibitors. Methods: In this multinational, open-label, single-group, phase 2 study, we enrolled patients with unresectable or metastatic FGFR2 fusion-positive or FGFR2 rearrangement-positive intrahepatic cholangiocarcinoma and disease progression after one or more previous lines of systemic therapy (excluding FGFR inhibitors). The patients received oral futibatinib at a dose of 20 mg once daily in a continuous regimen. The primary end point was objective response (partial or complete response), as assessed by independent central review. Secondary end points included the response duration, progression-free and overall survival, safety, and patient-reported outcomes. Results: Between April 16, 2018, and November 29, 2019, a total of 103 patients were enrolled and received futibatinib. A total of 43 of 103 patients (42%; 95% confidence interval, 32 to 52) had a response, and the median duration of response was 9.7 months. Responses were consistent across patient subgroups, including patients with heavily pretreated disease, older adults, and patients who had co-occurring TP53 mutations. At a median follow-up of 17.1 months, the median progression-free survival was 9.0 months and overall survival was 21.7 months. Common treatment-related grade 3 adverse events were hyperphosphatemia (in 30% of the patients), an increased aspartate aminotransferase level (in 7%), stomatitis (in 6%), and fatigue (in 6%). Treatment-related adverse events led to permanent discontinuation of futibatinib in 2% of the patients. No treatment-related deaths occurred. Quality of life was maintained throughout treatment. Conclusions: In previously treated patients with FGFR2 fusion or rearrangement-positive intrahepatic cholangiocarcinoma, the use of futibatinib, a covalent FGFR inhibitor, led to measurable clinical benefit.

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