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Updated Clinical Results Show Experimental Agent Ibrutinib as Highly Active in CLL Patients
Date:12/8/2012

umulative toxicity or long-term safety concerns with a median follow-up of 16 months for treated patients.

Study Methodology and Results

116 CLL patients were enrolled in the study in a series of treatment cohorts, which included patients who were never treated (treatment-nave); those who had received two or more prior therapies (relapsed/refractory); those who had relapsed within two years of treatment (high-risk); and those over age 65. Two oral dosing regimens (420 mg or 840 mg) of ibrutinib were used daily. The primary goal of the study was to determine the safety of the low and high doses. Secondary objectives included efficacy, measures of the intensity of the drug's effect in the body and the long-term safety of administering continuously until relapse.

The majority of adverse effects were diarrhea (54%), fatigue (29%), upper respiratory tract infection (29%), rash (28%), nausea (26%) and arthralgias (25%). Hematologic toxicity ≥ Gr 3 was relatively infrequent. There was no evidence of cumulative toxicity or long-term safety concerns with a median follow-up of 16 months. Estimated 22 month progression free survival for the 85 relapsed or refractory and high-risk patients was 76 percent and 96 percent for treatment-nave patients. Estimated 22 month overall survival for the 85 relapsed or refractory patients and high-risk patients was 85 percent and 96 percent for treatment-nave patients. Funding from Pharmacyclics, Inc., supports this clinical trial.


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Contact: Liz Bryan, Spectrum
lbryan@spectrumscience.com
443-506-1931
Ohio State University Medical Center
Source:Eurekalert

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