medwireNews: Treatment with the combination of ibrutinib and rituximab results in better outcomes for patients with newly diagnosed or recurrent Waldenström macroglobulinemia than rituximab alone, phase III trial findings indicate.
In the iNNOVATE study, the 75 participants who were randomly assigned to receive the Bruton tyrosine kinase inhibitor ibrutinib alongside the anti-CD20 agent rituximab had a significant 80% reduction in the risk for progression or death compared with their 75 counterparts given placebo plus rituximab. The corresponding progression-free survival (PFS) rates were 82% and 28%.
The PFS gain afforded by the addition of ibrutinib was maintained across all subgroups, report Meletios Dimopoulos (National and Kapodistrian University of Athens, Greece) and fellow investigators.
They note that “[t]he observed safety profile of ibrutinib–rituximab was similar to the known safety profiles of each agent used individually, and no unexpected toxic effects were identified.”
And the authors conclude: “[T]he addition of ibrutinib to rituximab represents a viable treatment approach for patients with Waldenström’s macroglobulinemia, both among those who have received no previous therapy and among those with disease recurrence, regardless of prognostic or genotypic factors.”
The study results were reported simultaneously at the ASCO Annual Meeting 2018 in Chicago, Illinois, USA, and published in The New England Journal of Medicine.
medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group