Final analysis of iNNOVATE study of ibrutinib plus rituximab for Waldenström’s macroglobulinemia

The multinational phase 3 study iNNOVATE randomized patients with Waldenström’s macroglobulinemia to ibrutinib-rituximab or placebo-rituximab. Final analysis of the study, with a median follow-up of 50 months, found longer progression-free survival with ibrutinib-rituximab compared to placebo-rituximab, regardless of MYD88 or CXCR4 mutation status and regardless of prior treatment. Partial response or better was seen in 76% with ibrutinib-rituximab versus 31% with placebo-rituximab (p<0.0001), median time to next treatment was not reached versus 18 months, and sustained hemoglobin improvement was seen in 77% versus 43% (p<0.0001). The safety profile of ibrutinib-rituximab was manageable.