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Pharmacyclics Announces Data Presentations for Ibrutinib in B-Cell Malignancies
Date:12/10/2013

nib (PCI-32765) Monotherapy Demonstrates Long-term Safety and Durability of Response in Chronic Lymphocytic Leukemia(CLL)/Small Lymphocytic Leukemia (SLL) Patients in an Open-Label Extension Study
Susan O'Brien, M.D., Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX

A long-term analysis of Phase 1/2 studies of single agent ibrutinib in 148 patients with CLL/SLL aimed to evaluate safety based on time on therapy, summarize safety findings in both the treatment-naive and relapsed/refractory (R/R) populations and assess overall response rate (ORR) and duration of response (DOR). The results showed that the percentage of patients who experienced a grade 3 or higher serious adverse event (SAE) declined over time from 43% within the first year of study treatment to 32% after the first year of treatment. Grade 3 or higher adverse events (AEs) and SAEs considered to be related directly to ibrutinib also declined notably compared to the first year of treatment: 24% and 8%, respectively, to 7% and 0%. The most frequent grade 3 or higher adverse events regardless of relationship to study drug were pneumonia (16.9%), hypertension (13.5%), neutropenia (11.5%), thrombocytopenia (7.4%) and diarrhea (5.4%).

Based on these patients the ORR was determined at 80.6% for treatment-naive patients, and 83.8% for R/R patients. The ORR plus partial response with lymphocytosis was 87.1% in the treatment-naive population and 88.9% in the R/R population. Median DOR was not reached in either population. At 30 months, 95.8% of treatment-naive and 69.7% of R/R responders were alive without disease progression.

-ORAL PRESENTATION- CLL Abstract #675:
Ibrutinib In Combination With Rituximab (iR) is Well Tolerated and Induces a High Rate of Durable Remissions in Patients With High-Risk Chronic Lymphocytic Leukemia (CLL): New, Updated Results Of a Phase II Trial I
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SOURCE Pharmacyclics, Inc.
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