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Pharmacyclics Reports CLL Results from Preclinical and Clinical Studies of its Btk Inhibitor PCI-32765
Date:12/5/2010

a (SLL): An Update on Ongoing Phase 1 Studies" is being presented by Jan Burger MD, PhD. This abstract describes clinical data from a pooled analysis of 54 CLL/SLL patients from a Phase Ia (N=16) and a Phase Ib/II (N=38) study.  Patients from the Phase Ia trial have relapsed/refractory CLL/SLL and have been treated for a median of approximately 8 months, while patients on the Phase Ib/II trial include two cohorts—one with relapsed or refractory disease and one with treatment-naive disease—who were just recently enrolled.

Response data from the pooled analysis is presented below.  Outcomes are described based on strict application of standard response criteria, with an additional outcome category termed "nodal response with lymphocytosis." This category describes patients with substantial lymph node (LN) shrinkage who have not yet achieved a 50% decrease of malignant B cells in the blood (lymphocytosis). The inclusion of this category is necessary because of the unique characteristics of response to this agent, especially early in treatment.  From the Ia trial, with approximately 8 months median follow-up, 1 patient achieved a complete response (CR) and 8/13 evaluable patients achieved a partial response (PR) for an objective response rate of 69%. Two additional patients achieved a nodal response with lymphocytosis (15%) and 2 patients had stable disease (SD).  Of note, 3 of the patients now classified as partial responses were initially nodal response with lymphocytosis earlier in treatment. In the Ib/II trial, with less than 2 months median follow-up, 8/32 evaluable patients achieved a PR (25%) by standard response criteria with an additional 17/32 (53%) achieving a nodal response with lymphocytosis.  Six other patients have SD. As noted previously, study of the patients from the Ia trial suggest that blood lymphocytosis decreases over time on treatment and patients who initially are described as nodal responses with lym
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