European Hematology Association: iNNOVATE Study: Ibrutinib Plus Rituximab for Patients With Waldenström's Macroglobulinemia

STOCKHOLM, June 16, 2018 /PRNewswire/ --

Waldenström's Macroglobulinemia (WM) is a rare type of blood cancer. Since WM is rare, it is difficult to conduct large clinical studies and determine a standard treatment for the disease. Rituximab, a therapy used to treat other types of blood cancer, is effective and commonly used in treating WM, by itself or when given with other treatments. Ibrutinib, an oral, once-daily inhibitor of Bruton's tyrosine kinase, is approved in the US for adults with WM and in the EU for adults previously treated for WM or with untreated WM that could not tolerate/receive chemotherapy. In this study, 150 patients with WM were randomly assigned to receive treatment with either ibrutinib+rituximab or placebo+rituximab, and physicians and patients did not know which treatment was given until the results were analyzed and the study was unblinded. More patients had a better response (major response rate) to treatment with ibrutinib+rituximab (72%) than with placebo+rituximab (32%). At 30 months after starting treatment, an estimated 82% of patients treated with ibrutinib+rituximab were alive and did not have disease progression versus 28% of patients treated with placebo+rituximab. It was estimated that 94% of patients treated with ibrutinib+rituximab and 92% of patients treated with placebo+rituximab would still be alive at 30 months after starting treatment. Approximately 60% of patients in both treatment groups experienced at least one significant (grade greater than or equal to3) side effect; the most common grade greater than or equal to3 side effects with ibrutinib+rituximab were hypertension (high blood pressure) and atrial fibrillation (irregular heartbeat). Ending treatment with ibrutinib or placebo because of side effects was uncommon (less than or equal to5% of patients in both treatment groups). Based on the data from this study, ibrutinib+rituximab could become a standard treatment option for WM.

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Presenter:  Dr Meletios Dimopoulos

Affiliation:  National and Kapodistrian University of Athens School of Medicine, Athens, Greece

Topic:  MULTINATIONAL, RANDOMIZED PHASE 3 TRIAL OF IBRUTINIB-RITUXIMAB VS PLACEBO-RITUXIMAB IN PATIENTS WITH WALDENSTRÖM'S MACROGLOBULINEMIA.

Abstract S852 will be presented by Meletios Dimopoulos on Saturday, June 16, 16:00-16:15 in Victoria Hall.

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SOURCE European Hematology Association