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

-cell malignancies, including several NHL subtypes, such as diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) and follicular lymphoma (FL). This study was an open-label, nonrandomized, multicenter study consisting of 2 parts: dose escalation in patients with DLBCL, MCL and FL (Part 1) and dose expansion only in DLBCL patients (Part 2). The primary objective of this phase 1B study in 33 patients was to determine the recommended phase 2 dose and dose-limiting toxicities of ibrutinib in combination with R-CHOP. Secondary objectives were to evaluate safety, ORR and pharmacokinetics. The results below focus on the 24 DLBCL patients across Parts 1 and 2 of the study.

Across Parts 1 and 2 (n=24), the most common all-grade treatment-emergent AEs (> 25%) were neutropenia (70.8%), nausea (66.7%), vomiting (66.7%), thrombocytopenia (58.3%), fatigue (50%), constipation (41.7%), anemia (41.7%), and diarrhea (33.3%). The most common Grade 3 or higher treatment-emergent AEs were neutropenia (66.7%), thrombocytopenia (16.7%), febrile neutropenia (16.7%), anemia (12.5%) and hypotension (8.3%).

The ORR for all evaluable patients across Parts 1 and 2 was 91.7%, with 83.3% of patients achieving a CR, and 8.3% achieving a PR.

Pre-Clinical and Non-Clinical Presentation Highlights

During the ASH meetings this year a total of 33 pre-clinical and non-clinical presentations were presented, 7 of these were oral and 26 poster presentations. The data presented provides further insights into ibrutinib including: 1) the potential reconstitution of the immune system in CLL patients 2) valuable findings of mechanism of action of ibrutinib 3) the apoptotic effect (cell death) of ibrutinib in both the tissue and blood for CLL cells and 4) many models illustrating combinations with many other therapies. Below are a select, few abstracts:

Poster Abstract #4182: In Patients With Chronic Lymphocytic Leukemia (CLL) Ibrutinib Effectivel
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SOURCE Pharmacyclics, Inc.
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