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Pharmacyclics Announces Data Presentations For Ibrutinib In B-Cell Malignancies

NEW ORLEANS, Dec. 10, 2013 /PRNewswire/ -- Pharmacyclics, Inc. (NASDAQ: PCYC) today announced results of 40 clinical, non-clinical and pre-clinical presentations on ibrutinib (IMBRUVICA ) at the 55 TH Annual meeting of the American Society of Hematology (ASH) held in New Orleans, Dec 7 - 10, 2013. There were seven presentations of clinical data, of which five were oral presentations, including one "Best of ASH" presentation on Waldenstrom's macroglobulinemia (WM). In total, 33 additional pre-clinical and non-clinical presentations provided new discoveries using ibrutinib; seven of these were oral presentations. The presentations further elucidated the mechanism of action of ibrutinib and its effect in the tumor microenvironment and provided data on quality of life changes. Results covered various B-cell malignancies: chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), WM, and non-Hodgkin lymphoma (NHL).

"The breadth of data presented at ASH this year demonstrates the scientific community's interest in ibrutinib and builds on the clinical responses seen with ibrutinib as a backbone of combination therapy and as a single agent in multiple B-cell malignancies," said Jesse McGreivy, M.D., Chief Medical Officer, Pharmacyclics. "This year's data explain ibrutinib's effect on the quality of life for patients and build on impressive efficacy and safety results, independent of cytogenetic risk factors. We also now have long-term follow-up in CLL, which suggests continuation of the efficacy and a decrease in overall and severe adverse events."

Clinical Trial Presentation Highlights

Chronic Lymphocytic Leukemia

-POSTER PRESENTATION- Abstract #4163: The Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib (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%).

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