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Efficacy, safety, and quality of life (QoL) with futibatinib in patients (pts) with intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 fusions/rearrangements: FOENIX-CCA2
Furuse, J. Goyal, L. Meric-Bernstam, F. Hollebecque, A. Valle, Juan W Morizane, C. Karasic, T. B. Abrams, T. A. Kelley, R. K. Cassier, P. A.
Furuse, J.
Goyal, L.
Meric-Bernstam, F.
Hollebecque, A.
Valle, Juan W
Morizane, C.
Karasic, T. B.
Abrams, T. A.
Kelley, R. K.
Cassier, P. A.
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Abstract
Background: iCCA has a poor prognosis and its incidence is higher in Asian vs Western
countries. Futibatinib is an oral, highly selective, irreversible FGFR1e4 inhibitor that
demonstrated safety and preliminary efficacy in pts with iCCA harboring FGFR2 aberrations.
This study evaluated safety, efficacy, and QoL with futibatinib treatment in
pts with iCCA and FGFR2 fusions/rearrangements.
Methods: FOENIX-CCA2 (NCT02052778), a global phase II study, enrolled pts with
unresectable/metastatic iCCA harboring an FGFR2 fusion/rearrangement and disease
progression after 1 line of systemic therapy (including gemcitabineecisplatin) but no
prior FGFR inhibitors. Pts received futibatinib 20 mg once daily until disease progression/
intolerability. The primary endpoint was objective response rate (ORR) per independent
central radiology review and RECIST v1.1; secondary endpoints were disease
control rate (DCR), duration of response (DOR), progression-free survival (PFS), safety,
and patient-reported outcomes (PROs). ORRs of subgroups by baseline demographic,
fusion partner, and other molecular alteration (eg, TP53) were also determined.
Results: Of 103 enrolled pts, planned interim data are reported for 67 pts (54% white,
24% Asian) with 6mo of follow-up; 55% of pts received 2 prior therapy lines, and 82%
had tumors harboring an FGFR2 fusion (BICC1, n¼15). ORR was 37.3%, DCR was 82.1%,
and median DOR was 8.3 mo. Objective responses occurred regardless of baseline
characteristic (subgroup: 65 y, ORR: 57.1%), FGFR2 fusion partner (BICC1, 33.3%), or
other genetic mutation (TP53, 16.7%). Median PFS was 7.2 mo. The most common
treatment-related adverse events (TRAEs; any grade/grade 3) were hyperphosphatemia
(81%/27%), diarrhea (37%/0%), and dry mouth (33%/0%); no grade 4e5 TRAEs occurred.
TRAEs were managed with dose interruption/reduction (55%/51%); only 1 pt discontinued
due to a TRAE. PROs were stable through 273 days (13 cycles) of treatment.
Conclusions: Futibatinib resulted in durable objective responses in pts with iCCA and
FGFR2 fusions/rearrangements, including within pt subgroups. Adverse events were
manageable, and QoL was maintained.
Description
Date
2020
Publisher
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Keywords
Type
Meetings and Proceedings
Citation
Furuse J, Goyal L, Meric-Bernstam F, Hollebecque A, Valle JW, Morizane C, et al. 116MO Efficacy, safety, and quality of life (QoL) with futibatinib in patients (pts) with intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 fusions/rearrangements: FOENIX-CCA2. Annals of Oncology. 2020;31:S1288-S9.