Reference Detail

Ref Type

PMID

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)

Journal	Vol	Issue	Date	Pages	Journal Short Title
Annals of Oncology	31	suppl_4

URL

https://www.sciencedirect.com/science/article/pii/S0923753420400286

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