The Janssen Pharmaceutical Companies of Johnson & Johnson have announced results from a pre-planned interim analysis of the Phase 3 iNNOVATE study evaluating Imbruvica® (ibrutinib) in combination with rituximab in relapsed/refractory and treatment-naïve patients with Waldenström’s macroglobulinemia (WM). The study met its primary endpoint for a clinically and statistically significant difference in progression-free survival (PFS) for patients treated with ibrutinib plus rituximab versus those who received placebo plus rituximab.
Ibrutinib plus rituximab significantly reduced the risk of disease progression or death by 80 percent compared to placebo plus rituximab. Furthermore, secondary endpoints including the response rate, time to next treatment (TTnT), rate of sustained haemoglobin improvement and number of participants with adverse events (AEs) supported the primary endpoint.
WM is a rare form of non-Hodgkin’s lymphoma (NHL). Incidence rates among men and women in Europe are approximately 7.3 and 4.2 per million persons, respectively. The causes of WM are unknown with it typically affecting older adults and slightly more common in men than women.
Dr. Meletios A. Dimopoulos, Professor and Chairman of the Department of Clinical Therapeutics and lead iNNOVATE study investigator said, “These important data demonstrate ibrutinib plus rituximab resulted in marked improvement in progression-free survival across all lines of therapy in Waldenström’s macroglobulinemia regardless of patient subtypes, compared to placebo plus rituximab.”