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

most common AEs, predominantly grade 1, were diarrhea (41%); arthralgia (30%); rash (27%); fatigue and bruising (20% each); and cramps (18%). The most common grade 3 or higher AEs were lung infection (5%) and rash (2%).

-ORAL PRESENTATION- CLL Abstract #525:
Ibrutinib in Combination With Bendamustine and Rituximab Is Active and Tolerable in Patients With Relapsed/Refractory CLL/SLL: Final Results Of a Phase 1b Study
Jennifer R. Brown, M.D., Ph.D., Dana-Farber Cancer Institute, Boston, MA

The primary objective of this study of 30 patients was to evaluate the safety of ibrutinib in combination with bendamustine and rituximab in patients with R/R CLL, and the secondary objectives were to evaluate the ORR and PFS. The observed safety profile for this novel combination was generally consistent with the safety profile of bendamustine and rituximab. The most frequently reported treatment-emergent AEs, regardless of attribution were predominantly grade 1 or 2, including diarrhea (70%), nausea (67%), fatigue (47%), neutropenia (40%) and upper respiratory tract infection (37%). The most frequently reported grade 3 or higher AEs were neutropenia (40%), rash and fatigue (10%each), thrombocytopenia and cellulitis (7% each), and febrile neutropenia (6%). Transient treatment-related lymphocytosis occurred less frequently in this combination than with ibrutinib monotherapy (Byrd et al, NEJM 2013).

With a median duration of treatment of 16 months, the ORR was 93.4% (28 out of 30 patients, including 5 CRs and 3nPRs), and one additional patient achieved a partial response with lymphocytosis. The median PFS has not been reached, and responses appeared to be independent of high-risk features. This combination is currently under investigation in a global Phase 3 trial.

Waldenstrom's Macroglobulinemia

-BEST OF ASH ORAL PRESENTATION- Abstract #25
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SOURCE Pharmacyclics, Inc.
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