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Follow-up Results of Phase 2 Study of Investigational Agent, Ibrutinib, in Relapsed/Refractory Mantle Cell Lymphoma Presented at American Society of Hematology Annual Meeting
Date:12/11/2012

ATLANTA, Dec. 11, 2012 /PRNewswire/ -- Janssen Research & Development, LLC, today announced follow-up findings from an ongoing, open-label, Phase 2, single-agent study showing that in patients with relapsed or refractory mantle cell lymphoma (MCL), the investigational oral agent ibrutinib (PCI-32765) resulted in an overall response rate (ORR) of 68 percent, including a complete response (CR) of 22 percent and a partial response (PR) of 46 percent. The study included both bortezomib-naive and bortezomib-exposed patients; 111 received ibrutinib and 110 were evaluable for efficacy. Median follow-up time was 9.2 months, with a range of time to response to treatment of 1.4 to 16.4 months.

The results were presented by lead investigator Michael L. Wang, M.D., associate professor in the Department of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center, at the 54th Annual Meeting of the American Society of Hematology (ASH) in Atlanta, GA. The findings extend the preliminary results reported by the investigators last year at ASH, which showed a similar ORR of 69 percent, including a CR of 16 percent and PR of 53 percent. Results were similar between the bortezomib-naive and bortezomib-exposed patients.

"With continued follow up, the overall response rate is similar to what we've reported before. In addition, the compound has presented a tolerable safety profile,"  said Dr. Wang. "The data build on our knowledge and support the continued study of ibrutinib to determine its potential role as a treatment option for patients with relapsed or refractory MCL, a population that is currently difficult to treat."

Relapsed MCL means the disease has returned after an initial partial or total remission. Refractory MCL refers to cancer that does not respond to current treatment.

Among the study's secondary endpoints, the median progression-free survival (PFS) with ibrutinib was 13.9 months. Additionally, the m
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SOURCE Janssen Research & Development, LLC
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