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Ref Type Journal Article
PMID (36652354)
Authors Goyal L, Meric-Bernstam F, Hollebecque A, Valle JW, Morizane C, Karasic TB, Abrams TA, Furuse J, Kelley RK, Cassier PA, Klümpen HJ, Chang HM, Chen LT, Tabernero J, Oh DY, Mahipal A, Moehler M, Mitchell EP, Komatsu Y, Masuda K, Ahn D, Epstein RS, Halim AB, Fu Y, Salimi T, Wacheck V, He Y, Liu M, Benhadji KA, Bridgewater JA, FOENIX-CCA2 Study Investigators
Title Futibatinib for FGFR2-Rearranged Intrahepatic Cholangiocarcinoma.
Journal Vol Issue Date Pages Journal Short Title
The New England journal of medicine 388 3 2023 Jan 19 228-239 N Engl J Med
URL
Abstract Text 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.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.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.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. (Funded by Taiho Oncology and Taiho Pharmaceutical; FOENIX-CCA2 ClinicalTrials.gov number, NCT02052778.).

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR2 fusion intrahepatic cholangiocarcinoma sensitive Futibatinib FDA approved Actionable In a Phase II trial (FOENIX-CCA2) that supported FDA approval, Lytgobi (futibatinib) demonstrated safety and resulted in an objective response rate of 42% (43/103, 1 complete response, 42 partial responses), disease control rate of 83% (85/103), median duration of response of 9.7 mo, median progression-free survival of 9.0 mo, and median overall survival of 21.7 mo in patients with advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements (PMID: 36652354; NCT02052778). detail... 36652354
FGFR2 rearrange intrahepatic cholangiocarcinoma sensitive Futibatinib FDA approved Actionable In a Phase II trial (FOENIX-CCA2) that supported FDA approval, Lytgobi (futibatinib) demonstrated safety and resulted in an objective response rate of 42% (43/103, 1 complete response, 42 partial responses), disease control rate of 83% (85/103), median duration of response of 9.7 mo, median progression-free survival of 9.0 mo, and median overall survival of 21.7 mo in patients with advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements (PMID: 36652354; NCT02052778). detail... 36652354