AbbVie issued the following announcement on June 1.
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced findings from an interim analysis of the Phase 3 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.1
These data were presented today in an oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (abstract #8003) and were simultaneously published in The New England Journal of Medicine. The data were also selected for the 2018 Best of ASCO Meetings. 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 U.S. Food and Drug Administration (FDA) for review. The Independent Data Monitoring Committee (IDMC) in late 2017 recommended unblinding iNNOVATE based on these positive findings.
"The iNNOVATE study provides further evidence of the potential clinical benefit of IMBRUVICA-based combination therapy in patients with Waldenström's macroglobulinemia," said Thorsten Graef, M.D., Ph.D., Head of Clinical Development at Pharmacyclics LLC, an AbbVie company. "The data from this chemotherapy-free combination regimen suggests that patients with Waldenström's macroglobulinemia, including those who are newly diagnosed, could have another beneficial therapeutic option in the future."
WM is a rare and incurable form of NHL with limited treatment options. There are about 2,800 new cases of WM in the U.S. each year. In January 2015, IMBRUVICA received FDA approval for all lines of treatment in WM and is the first and only FDA-approved therapy specifically indicated for this disease. IMBRUVICA has been available in the U.S. since 2013 and is FDA-approved for use in five B-cell blood cancers, as well as previously-treated chronic graft-versus-host disease. IMBRUVICA is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.
"The iNNOVATE trial broadens our understanding about how to treat patients with WM, including those with certain subtypes or genomic abnormalities," said Dr. Meletios A. Dimopoulos, Professor and Chairman of the Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine, Athens, Greece and lead investigator of the iNNOVATE study.* "As a clinician, I'm hopeful that the data from iNNOVATE could potentially lead to a new option for treating this rare and incurable disease."
To view all IMBRUVICA company-sponsored or investigator-initiated studies being presented at ASCO 2018, please visit: https://meetinglibrary.asco.org/.
Original source can be found here.