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

n 40 Patients
Jan A. Burger, M.D., Ph.D., Department of Leukemia, MD Anderson Cancer Center, Houston, TX

The objectives of this study were to assess the activity and tolerability of ibrutinib and rituximab in combination, in high-risk CLL patients. The study included 40 patients with CLL, with a median of two prior therapies. Twenty of the patients had del 17p mutations and 13 patients had del11q. Thirty-four patients (85%) achieved a partial response (PR), and four (10%) achieved a complete response (CR), leading to an ORR of 95%. One of four CRs were negative for minimal residual disease (MRD) by flow cytometry.

The most common AEs related to treatment, all grade 1 or 2, were diarrhea (n=17), bruising/rash (n=14), arthalgia (n=13), nausea/acid reflux (n=10) and upper respiratory infection (n=9). The most common grade 3 or higher AEs related to treatment were lung infection (n=4), peripheral neuropathy (n=3), neutropenia (n=2), mucositis (n=2) and increased ALT (n=1).

Questionnaires revealed improved overall health and quality of life after 6 months, based on Quality of Life questionnaire (EORTC-QOL-v.3), with 89% of patients reporting a high quality of life score (6 to 7) compared to 46% at baseline and patients achieved a statistically significant increase in body weight.

-POSTER PRESENTATION- CLL Abstract #2872:
Changing the Treatment Paradigm for Previously Treated Chronic Lymphocytic Leukemia Patients with Del(17p) Karyotype
Deborah M. Stephens, D.O., Division of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, OH

This retrospective analysis aimed to describe the success of treatment of del 17p patients on clinical trials at The Ohio State University (OSU). The study reviewed records of 174 CLL patients with del 17p who had received prior therapy.

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SOURCE Pharmacyclics, Inc.
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