A phase III clinical study of imbruvica combined with rituximab in the treatment of megaglobulinemia of Fahrenheit reached the primary end point

WM is a rare type of non-Hodgkin's lymphoma, which is characterized by a large number of monoclonal megaglobulin (IgM) in the blood and bone marrow infiltration of plasma cell lymphoma In the United States, about 1000-1500 patients with WM are diagnosed each year Recently, the US biotech giant eberway announced that the evaluation of the targeted anticancer drug imbruvica (ibrutinib, irutini) combined with Swiss pharmaceutical (http:// Rinovate (pcyc-1127), a phase III clinical study of rituxan (general name: Rituximab) in the treatment of megaglobulinemia of Fahrenheit (WM), reached the main end point The related study, innovate, was a randomized, double-blind, placebo-controlled study conducted by a company affiliated with Aberdeen (http:// Sponsored by pharmacyclics, we evaluated the efficacy and safety of the combination of rituximab and irutinib compared with rituximab in 150 patients with recurrent / refractory and untreated WM In the study, patients received rituximab (375mg / m2, once a week for 4 weeks, once a week for the second 4 weeks after an interval of 3 months), and all patients received daily oral administration of elutinib (420mg) or placebo, and continued treatment until reaching the standard of permanent discontinuation The primary end point of the study was progression free survival (PFS), and the secondary end points included total remission rate, hematologic remission of hemoglobin determination, time for next treatment, total survival period and incidence of adverse events, as indicators of safety and tolerance in each treatment group A pre-defined mid-term analysis (http:// showed that the combination of irudinib and rituximab significantly prolonged PFS and reached the primary end point compared to rituximab alone Based on the positive data from this analysis, the independent data monitoring committee (IDMC) has recommended that the study be unblinded Irutinib is the first Btk inhibitor developed by Alberto and Johnson & Johnson Both parties have planned to share the interim analysis data of the study with regulatory authorities, and will publish detailed data in peer review journals or future medical conferences (http:// In January 2015, imbruvica was approved by the US FDA (http:// for use in adult patients with WM who have previously received treatment (treated) and have not received treatment (primary treatment) Previously, the FDA also granted the breakthrough drug (http:// qualification (BTD) to treat WM