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:2/8/2016)... MD (PRWEB) , ... February 08, 2016 , ... ... is excited to share this important news! AHCC and the Home Health and ... Coding Clinic, CMS' designee for official ICD coding guidance and clarifications, to address ...
(Date:2/8/2016)... ... 2016 , ... The schedule is now online for the largest ... which is being held May 25-29 at the Loews Chicago O’Hare Hotel, continues to ... causes of chronic illness in children. , Very recent articles have cited 1 child ...
(Date:2/7/2016)... ... 2016 , ... HealthSmart Holdings, Inc. announced today the launch ... and information to lower the costs, and increase the impact of their healthcare ... healthcare benefits by as much as 22%:, + Price and quality transparency, ...
(Date:2/6/2016)... ... ... With the FCPX LUT: Summer pack from Pixel Film Studios, ... is a Lookup Table that contains a mathematical formula for modifying an image. The ... manipulating each pixel, LUT's can change each color range differently, it gives the user ...
(Date:2/5/2016)... ... February 05, 2016 , ... Love is in the ... a variety of colors, assortments and packaging. This staple for Valentine’s Day is a ... location. , For Valentine’s Day, not only are long-stem roses available, but also ...
Breaking Medicine News(10 mins):
(Date:2/8/2016)... PALO ALTO, Calif. , Feb. 8, 2016 ... chemical manufacturing, and Kodiak Sciences Inc., a biopharmaceutical company ... retinal disease, announced today agreements for the clinical supply ... manufacture material at multiple sites, including Slough (UK), Visp ... --> Retinal diseases, such as age-related ...
(Date:2/8/2016)... N.C. , Feb. 8, 2016  Avista Pharma ... Eric Setzer as Chief Financial Officer (CFO). Mr. ... twenty years of experience in various roles within growing ... Pharma, he served as the Executive Director of Finance ... in Raleigh, NC . Previously, Mr. ...
(Date:2/8/2016)... Vestagen Technical Textiles, Inc., a medical technology ... and other demanding applications, today announced it has named ... Dale Pfost , PhD, who was serving as ... joining Vestagen,s Board of Directors. ® , ... technologies that combines fluid repellent, antimicrobial and breathability properties. ...
Breaking Medicine Technology: