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

ts' first treatment at OSU (OSU Tx1), 16% (n=27), 33% (n=58), and 51% (n=89) of pts received an ibrutinib-based therapy, cyclin-dependent kinase inhibitor-based therapy (CDKi), or other therapies (O), respectively.

The ORR was significantly different among groups at 56%, 45%, and 24% in the ibrutinib, CDKi, and O groups, respectively. 12-month progression free survival (PFS) estimates were 77%, 38%, and 17% in the ibrutinib, CDKi, and O groups, respectively. 12-month overall survival (OS) estimates were 81%, 78%, and 58%. Notably, age did not correlate with response, PFS, or OS.

-ORAL PRESENTATION- CLL Abstract #673:
Single Agent Ibrutinib Achieves Equal Responses in CLL Patients With and Without Deletion 17p
Mohammed Farooqui, DO, National Institutes of Health, National Heart, Lung and Blood Institute, Bethesda, MD

This phase 2, single center, study of ibrutinib as a single-agent aimed to address the role of ibrutinib in the treatment of CLL patients with del 17p, regardless of their prior treatment history. The study enrolled 29 patients with del 17p, and 24 elderly patients without del 17p (NL 17p). Fifteen of the del 17p patients and eight of the NL 17p patients were treatment naive. The primary endpoint of the study was response after 6 months, assessed by computed tomography (CT) scans, bone marrow biopsies, and routine clinical and laboratory studies.

At six months, 47 patients were evaluable. Of the patients with del 17p, 53% achieved a PR and 43% achieved a PRL, compared to 82% PR and 9% PRL among the NL 17p patients. The apparent difference in response rates is due to slower clearance of the treatment-induced lymphocytosis in the del 17p patients; however, the clinical benefit and disease control in all tissue sites was equal for both cohorts of patients. Twenty-month PFS was 100% in the NL 17p cohort, and 85% in the del 17p cohort.

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SOURCE Pharmacyclics, Inc.
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