Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia

J. C. Byrd, J. R. Brown, S. O'Brien, J. C. Barrientos, N. E. Kay, N. M. Reddy, S. Coutre, C. S. Tam, S. P. Mulligan, U. Jaeger, S. Devereux, P. M. Barr, R. R. Furman, T. J. Kipps, F. Cymbalista, C. Pocock, P. Thornton, F. Caligaris-Cappio, T. Robak, J. DelgadoS. J. Schuster, M. Montillo, A. Schuh, S. De Vos, D. Gill, A. Bloor, C. Dearden, C. Moreno, J. J. Jones, A. D. Chu, M. Fardis, J. McGreivy, F. Clow, D. F. James, P. Hillmen

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Abstract

BACKGROUND: In patients with chronic lymphoid leukemia (CLL) or small lymphocytic lymphoma (SLL), a short duration of response to therapy or adverse cytogenetic abnormalities are associated with a poor outcome. We evaluated the efficacy of ibrutinib, a covalent inhibitor of Bruton's tyrosine kinase, in patients at risk for a poor outcome. METHODS: In this multicenter, open-label, phase 3 study, we randomly assigned 391 patients with relapsed or refractory CLL or SLL to receive daily ibrutinib or the anti-CD20 antibody ofatumumab. The primary end point was the duration of progression-free survival, with the duration of overall survival and the overall response rate as secondary end points. RESULTS: At a median follow-up of 9.4 months, ibrutinib significantly improved progressionfree survival; the median duration was not reached in the ibrutinib group (with a rate of progression-free survival of 88% at 6 months), as compared with a median of 8.1 months in the ofatumumab group (hazard ratio for progression or death in the ibrutinib group, 0.22; P

Original languageEnglish
Pages (from-to)213-223
Number of pages11
JournalNew England Journal of Medicine
Volume371
Issue number3
DOIs
Publication statusPublished - 2014

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Lymphoid Leukemia
B-Cell Chronic Lymphocytic Leukemia
Disease-Free Survival
Survival
Chromosome Aberrations
Anti-Idiotypic Antibodies
PCI 32765
ofatumumab

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Byrd, J. C., Brown, J. R., O'Brien, S., Barrientos, J. C., Kay, N. E., Reddy, N. M., ... Hillmen, P. (2014). Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. New England Journal of Medicine, 371(3), 213-223. https://doi.org/10.1056/NEJMoa1400376

Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. / Byrd, J. C.; Brown, J. R.; O'Brien, S.; Barrientos, J. C.; Kay, N. E.; Reddy, N. M.; Coutre, S.; Tam, C. S.; Mulligan, S. P.; Jaeger, U.; Devereux, S.; Barr, P. M.; Furman, R. R.; Kipps, T. J.; Cymbalista, F.; Pocock, C.; Thornton, P.; Caligaris-Cappio, F.; Robak, T.; Delgado, J.; Schuster, S. J.; Montillo, M.; Schuh, A.; De Vos, S.; Gill, D.; Bloor, A.; Dearden, C.; Moreno, C.; Jones, J. J.; Chu, A. D.; Fardis, M.; McGreivy, J.; Clow, F.; James, D. F.; Hillmen, P.

In: New England Journal of Medicine, Vol. 371, No. 3, 2014, p. 213-223.

Research output: Contribution to journalArticle

Byrd, JC, Brown, JR, O'Brien, S, Barrientos, JC, Kay, NE, Reddy, NM, Coutre, S, Tam, CS, Mulligan, SP, Jaeger, U, Devereux, S, Barr, PM, Furman, RR, Kipps, TJ, Cymbalista, F, Pocock, C, Thornton, P, Caligaris-Cappio, F, Robak, T, Delgado, J, Schuster, SJ, Montillo, M, Schuh, A, De Vos, S, Gill, D, Bloor, A, Dearden, C, Moreno, C, Jones, JJ, Chu, AD, Fardis, M, McGreivy, J, Clow, F, James, DF & Hillmen, P 2014, 'Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia', New England Journal of Medicine, vol. 371, no. 3, pp. 213-223. https://doi.org/10.1056/NEJMoa1400376
Byrd, J. C. ; Brown, J. R. ; O'Brien, S. ; Barrientos, J. C. ; Kay, N. E. ; Reddy, N. M. ; Coutre, S. ; Tam, C. S. ; Mulligan, S. P. ; Jaeger, U. ; Devereux, S. ; Barr, P. M. ; Furman, R. R. ; Kipps, T. J. ; Cymbalista, F. ; Pocock, C. ; Thornton, P. ; Caligaris-Cappio, F. ; Robak, T. ; Delgado, J. ; Schuster, S. J. ; Montillo, M. ; Schuh, A. ; De Vos, S. ; Gill, D. ; Bloor, A. ; Dearden, C. ; Moreno, C. ; Jones, J. J. ; Chu, A. D. ; Fardis, M. ; McGreivy, J. ; Clow, F. ; James, D. F. ; Hillmen, P. / Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. In: New England Journal of Medicine. 2014 ; Vol. 371, No. 3. pp. 213-223.
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T1 - Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia

AU - Byrd, J. C.

AU - Brown, J. R.

AU - O'Brien, S.

AU - Barrientos, J. C.

AU - Kay, N. E.

AU - Reddy, N. M.

AU - Coutre, S.

AU - Tam, C. S.

AU - Mulligan, S. P.

AU - Jaeger, U.

AU - Devereux, S.

AU - Barr, P. M.

AU - Furman, R. R.

AU - Kipps, T. J.

AU - Cymbalista, F.

AU - Pocock, C.

AU - Thornton, P.

AU - Caligaris-Cappio, F.

AU - Robak, T.

AU - Delgado, J.

AU - Schuster, S. J.

AU - Montillo, M.

AU - Schuh, A.

AU - De Vos, S.

AU - Gill, D.

AU - Bloor, A.

AU - Dearden, C.

AU - Moreno, C.

AU - Jones, J. J.

AU - Chu, A. D.

AU - Fardis, M.

AU - McGreivy, J.

AU - Clow, F.

AU - James, D. F.

AU - Hillmen, P.

PY - 2014

Y1 - 2014

N2 - BACKGROUND: In patients with chronic lymphoid leukemia (CLL) or small lymphocytic lymphoma (SLL), a short duration of response to therapy or adverse cytogenetic abnormalities are associated with a poor outcome. We evaluated the efficacy of ibrutinib, a covalent inhibitor of Bruton's tyrosine kinase, in patients at risk for a poor outcome. METHODS: In this multicenter, open-label, phase 3 study, we randomly assigned 391 patients with relapsed or refractory CLL or SLL to receive daily ibrutinib or the anti-CD20 antibody ofatumumab. The primary end point was the duration of progression-free survival, with the duration of overall survival and the overall response rate as secondary end points. RESULTS: At a median follow-up of 9.4 months, ibrutinib significantly improved progressionfree survival; the median duration was not reached in the ibrutinib group (with a rate of progression-free survival of 88% at 6 months), as compared with a median of 8.1 months in the ofatumumab group (hazard ratio for progression or death in the ibrutinib group, 0.22; P

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U2 - 10.1056/NEJMoa1400376

DO - 10.1056/NEJMoa1400376

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