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    Extended follow-up and impact of high-risk prognostic factors from the phase 3 RESONATE study in patients with previously treated CLL/SLL

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    118
    Author
    Brown, JR; Hillmen, P; O'Brien, S; Barrientos, JC; Reddy, NM; Coutre, SE; Tam, CS; Mulligan, SP; Jaeger, U; Barr, PM; ...
    Date
    2018-01-01
    Source Title
    Leukemia
    Publisher
    NATURE PUBLISHING GROUP
    University of Melbourne Author/s
    Tam, Constantine
    Affiliation
    Medicine and Radiology
    Metadata
    Show full item record
    Document Type
    Journal Article
    Citations
    Brown, J. R., Hillmen, P., O'Brien, S., Barrientos, J. C., Reddy, N. M., Coutre, S. E., Tam, C. S., Mulligan, S. P., Jaeger, U., Barr, P. M., Furman, R. R., Kipps, T. J., Cymbalista, F., Thornton, P., Caligaris-Cappio, F., Delgado, J., Montillo, M., DeVos, S., Moreno, C. ,... Byrd, J. C. (2018). Extended follow-up and impact of high-risk prognostic factors from the phase 3 RESONATE study in patients with previously treated CLL/SLL. LEUKEMIA, 32 (1), pp.83-91. https://doi.org/10.1038/leu.2017.175.
    Access Status
    Open Access
    URI
    http://hdl.handle.net/11343/259532
    DOI
    10.1038/leu.2017.175
    Abstract
    In the phase 3 RESONATE study, ibrutinib demonstrated superior progression-free survival (PFS), overall survival (OS) and overall response rate (ORR) compared with ofatumumab in relapsed/refractory CLL patients with high-risk prognostic factors. We report updated results from RESONATE in these traditionally chemotherapy resistant high-risk genomic subgroups at a median follow-up of 19 months. Mutations were detected by Foundation One Heme Panel. Baseline mutations in the ibrutinib arm included TP53 (51%), SF3B1 (31%), NOTCH1 (28%), ATM (19%) and BIRC3 (14%). Median PFS was not reached, with 74% of patients randomized to ibrutinib alive and progression-free at 24 months. The improved efficacy of ibrutinib vs ofatumumab continues in all prognostic subgroups including del17p and del11q. No significant difference within the ibrutinib arm was observed for PFS across most genomic subtypes, although a subset carrying both TP53 mutation and del17p had reduced PFS compared with patients with neither abnormality. Reduced PFS or OS was not evident in patients with only del17p. PFS was significantly better for ibrutinib-treated patients in second-line vs later lines of therapy. The robust clinical activity of ibrutinib continues to show ongoing efficacy and acceptable safety consistent with prior reports, independent of various known high-risk mutations.

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