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

COLUMBUS, Ohio Updated results from a Phase Ib/II clinical trial indicates that a novel therapeutic agent for chronic lymphocytic leukemia (CLL) is highly active and well tolerated in patients who have relapsed and are resistant to other therapy.

The agent, ibrutinib (PCI-32765), is the first drug designed to target Bruton's tyrosine kinase (BTK), a protein essential for CLL-cell survival and proliferation. CLL is the most common form of leukemia, with about 15,000 new cases annually in the U.S. About 4,400 Americans die of the disease each year.

Study co-leader Dr. John C. Byrd, director of the division of hematology at Ohio State University Comprehensive Cancer Center Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC James) presented these findings today (12/8) at the 54th Annual Meeting of the American Society of Hematology (ASH) Annual Meeting in Atlanta, GA.

The study found that response to therapy was high across cohorts, with 71 percent of previously untreated older patients experiencing a complete or partial response at either treatment dose (420mg and 840mg). The same response was observed in 67 percent of the relapsed patients and half (50%) of the high-risk patient cohort. After 22 months of follow-up, the disease had not progressed in 96 percent of previously untreated patients and 76 percent of relapsed and high-risk patients.

"These findings are truly exciting because they demonstrate ibrutinib's potential as a highly active, well-tolerated first-line therapy for CLL that produces a high rate of durable remissions the remissions last months on end," Byrd says. "The drug is effective in part because patients are willing to stay on treatment since the side effects are very tolerable," he states.

Only non-severe side effects, including diarrhea, fatigue, chest infection, rash, nausea, joint pain and infrequent and transient low blood counts were observed. Investigators found no evidence of cumulative 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.


'/>"/>

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

Related medicine news :

1. EzCheckPrinting Updated with New Category Feature to Simplify Check Printing and Tax Reporting
2. Winning the battle against leukaemia: Positive early results in clinical trial for DNA vaccine
3. Pure Cocoa Powder, the Key Ingredient in Dark Chocolate and Found in Diabetes Support Supplements has been Clinically Proven to Reduce Cardiovascular Risk
4. USC Norris cancer research ranks among top clinical advances for 2012
5. American Society of Clinical Oncology issues annual report on state of clinical cancer science
6. Clinical trial at GHSU Cancer Center targets advanced prostate cancer
7. Study finds link between access to online health information and use of clinical services
8. Edison Pharmaceuticals announces initiation of EPI-743 Phase 2B Leigh Syndrome Clinical Trial
9. Molecular portraits of tumours match patients with trials in everyday clinical practice
10. New targeted therapy for advanced prostate cancer shows anti-tumor activity in clinical trials
11. Spread of human melanoma cells in mice correlates with clinical outcomes in patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2017)... ... ... of a visit to San Francisco , fall is a great time to visit. ... Business Architecture Associates is pleased to offer 5 days of training courses, available to the ... individuals, and as 4-½ day corporate package for up to 3 employees with the option ...
(Date:5/24/2017)... ... 2017 , ... Technique, technique, technique – with a dash of common sense. ... training and exercise or simply lifting heavy objects, advises Dr. Kaliq Chang, interventional pain ... Chang says. “Improper technique in lifting anything heavy or an attempt to lift too ...
(Date:5/23/2017)... (PRWEB) , ... May 23, 2017 , ... ... the pharmaceutical and medical device sectors, today announced the winners of its 3rd ... Entrepreneurs) represent the most influential people in the healthcare industry today. , Out ...
(Date:5/23/2017)... ... 2017 , ... London, May 23, 2017: Walter Schindler, the Founder and Managing ... Guest Speaker and Contributor to a weeklong series of classes, meetings, field trips and ... , Walter Schindler and SAIL Capital have received an increasing number ...
(Date:5/23/2017)... ... 2017 , ... Diagnotes, an Indianapolis-based digital healthcare communication company, ... secure clinical communication platform. The platform allows clinicians to easily escalate their preferred ... urgency of a situation. , “We know from our daily lives that ...
Breaking Medicine News(10 mins):
(Date:5/23/2017)... May 23, 2017  Leaf Healthcare, recognized for ... devices for pressure ulcer prevention, will unveil its ... of Critical Care Nurses, National Teaching Institute and ... The Leaf Patient Monitoring System is the ... hospital environment.  The system seamlessly tracks patient movement ...
(Date:5/18/2017)... -- Two Bayer U.S. Pharmaceutical leaders received top awards from ... th Woman of the Year event ... mission of furthering the advancement and impact of women ... Powell-Steffen , senior director of brand activation and inside ... Howe , a regional business manager for New England ...
(Date:5/15/2017)... , May 15, 2017 Enterin Inc., a privately-held ... and developing novel compounds to treat Parkinson,s disease (PD), has ... is a Phase 1/2a randomized, controlled, multicenter study involving patients ... will enroll 50 patients over a 9-to-12-month period. The first ... 10 patients with PD. Participating sites include Denver ...
Breaking Medicine Technology: