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Authors J.Bridgewater, F.Meric-Bernstam, A.Hollebecque, J.W.Valle, C.Morizane, T.Karasic, T.Abrams, J.Furuse, R.K.Kelley, P.Cassier, H-J.Klümpen, N.Uboha, A.Mahipal, E.Mitchell, E.R.Ahn, H-M.Chang, K.Masuda, Y.He, K.Benhadji, L.Goyal
Title Efficacy and safety of futibatinib in intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 fusions/other rearrangements: Subgroup analyses of a phase II study (FOENIX-CCA2)
Abstract Text Background: FGFR2 fusions occur in 10–20% of pts with iCCA and comutations in tumor suppressor genes may be prognostic. FOENIX-CCA2 is a study of futibatinib (a highly selective irreversible FGFR1–4 inhibitor) in pts with iCCA and FGFR2 fusions/other rearrangements. Methods: Pts enrolled had locally advanced/metastatic iCCA with FGFR2 fusions/other rearrangements, progressive disease (PD) after ≥1 systemic therapy (tx), no prior FGFR inhibitor tx, and ECOG PS 0/1. Pts received oral futibatinib 20 mg 1x/day until PD/intolerance. Objective response rate (ORR; independent review) was the primary endpoint and duration of response (DOR), PFS and safety were secondary endpoints. Subanalyses by pt characteristic, fusion, comutation and prognostic factor were performed. Results: Interim data for 67 pts (58% female; median age 57 y) with ≥6 mo of follow-up are reported. Pts had FGFR2 fusions (82%) or rearrangements (18%). The most frequent fusion was FGFR2-BICC1 (n=15). ORR was 37.3%, median DOR 8.3 mo, and disease control rate 82%. In pts with confirmed FGFR2 alterations, ORR was 36.2% (21/58 fusions) and 44.4% (4/9 rearrangements). ORR was 33.3% in pts with FGFR2-BICC1. Best overall response in pts with comutations of interest is shown in the table below. All baseline characteristic subgroups (eg, age, gender, prior tx) had responding pts, including pts aged ≥65 y (ORR=57%; 8/14). Higher phosphate levels trended in responders vs nonresponders. Grade ≥3 treatment-related hyperphosphatemia resolved in a median of 6 d. Management of special interest AEs will be presented. Conclusions: These interim data demonstrate manageable AEs and efficacy of futibatinib in iCCA with FGFR2 fusions/other rearrangements. Responses were observed across pt subgroups, including those with common FGFR2 fusions, comutations, and poor prognostic factors. Clinical trial identification: NCT02052778; EudraCT: 2013-004810-16.


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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