Phase III iNNOVATE study of Imbruvica plus Rituxan meets endpoint in Waldenström's macroglobulinemia.- AbbVie.

AbbVie has announced findings from an interim analysis of the Phase III iNNOVATE (PCYC-1127) study evaluating Imbruvica (ibrutinib) plus Rituxan (rituximab) in previously untreated and relapsed/refractory patients with Waldenström's macroglobulinemia (WM), a rare type of non-Hodgkin's lymphoma (NHL). At a median follow up of 26.5 months, the study successfully met its primary endpoint, demonstrating a significant improvement in progression-free survival (PFS) with ibrutinib plus rituximab compared to rituximab alone (30 month PFS rates were 82 percent versus 28 percent, respectively). Patients taking ibrutinib plus rituximab also experienced an 80 percent reduction in relative risk of disease progression or death than those only treated with rituximab (hazard ratio, 0.20; confidence interval: 0.11-0.38, P <0.0001). Additionally, the data found that the combination with ibrutinib provided reductions in infusion reactions associated with rituximab and immunoglobin M (IgM) flare.

With the support of these positive findings, a supplemental New Drug Application (sNDA) to expand the use of Imbruvica as a combination therapy in WM was submitted to the FDA for review. The Independent Data Monitoring Committee in late 2017 recommended unblinding iNNOVATE based on these positive findings. These data were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting and were simultaneously published in The New England Journal of Medicine.