Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia.
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Byrd John C, Brown Jennifer R, O'Brien Susan, Barrientos Jacqueline C, Kay Neil E, Reddy Nishitha M, Coutre Steven, Tam Constantine S, Mulligan Stephen P, Jaeger Ulrich, Devereux Steve, Barr Paul M, Furman Richard R, Kipps Thomas J, Cymbalista Florence, Pocock Christopher, Thornton Patrick, Caligaris-Cappio Federico, Robak Tadeusz, Delgado Julio, Schuster Stephen J, Montillo Marco, Schuh Anna, de Vos Sven, Gill Devinder, Bloor Adrian, Dearden Claire, Moreno Carol, Jones Jeffrey J, Chu Alvina D, Fardis Maria, McGreivy Jesse, Clow Fong, James Danelle F, Hillmen Peter, RESONATE Investigators
Аннотация
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 progression-free 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<0.001). Ibrutinib also significantly improved overall survival (hazard ratio for death, 0.43; P=0.005). At 12 months, the overall survival rate was 90% in the ibrutinib group and 81% in the ofatumumab group. The overall response rate was significantly higher in the ibrutinib group than in the ofatumumab group (42.6% vs. 4.1%, P<0.001). An additional 20% of ibrutinib-treated patients had a partial response with lymphocytosis. Similar effects were observed regardless of whether patients had a chromosome 17p13.1 deletion or resistance to purine analogues. The most frequent nonhematologic adverse events were diarrhea, fatigue, pyrexia, and nausea in the ibrutinib group and fatigue, infusion-related reactions, and cough in the ofatumumab group.
CONCLUSIONS: Ibrutinib, as compared with ofatumumab, significantly improved progression-free survival, overall survival, and response rate among patients with previously treated CLL or SLL. (Funded by Pharmacyclics and Janssen; RESONATE ClinicalTrials.gov number, NCT01578707.).