Encouraging Data from a Phase 1b/2, Open-label, Multicenter Study

RARITAN, NJ - December 9, 2013 - Janssen Research & Development, LLC (Janssen) today announced data from a study published in The Lancet Oncology, evaluating the safety and activity of ibrutinib as a single-agent therapy in patients over the age of 65 with previously untreated chronic lymphocytic leukemia (CLL, N=29) or small lymphocytic lymphoma (SLL, N=2). The study met its primary endpoint of safety, with data demonstrating treatment with ibrutinib as an initial therapy was associated with adverse events (AEs) that were predominantly Grade 1 or 2 in nature.

Efficacy data were also collected and showed that 71 percent (95% CI, 52.0-85.8) of patients treated with ibrutinib achieved an objective response (defined as a complete or partial response). Although estimates of progression-free survival (PFS) and overall survival (OS) were not reached at the median follow up of 22.1 months, it is estimated that more than 95% of patients would be alive and progression-free at two years.

"This early stage study in previously untreated patients suggests a positive effect with ibrutinib in CLL and SLL," said lead author Susan O'Brien, M.D., Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. "The results of this study are encouraging given the average age, overall health and unmet needs of the typical CLL population."

Primary Endpoint: Safety
Adverse events were predominantly Grade 1 or 2 in severity, with the most frequently (

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