Featured Research

from universities, journals, and other organizations

Updated clinical results show experimental agent ibrutinib as highly active in CLL patients

Date:
December 8, 2012
Source:
Ohio State University Medical Center
Summary:
Updated results from early phase 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, a protein essential for CLL-cell survival and proliferation.

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 December 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-naοve); 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-naοve 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-naοve patients. Funding from Pharmacyclics, Inc., supports this clinical trial.


Story Source:

The above story is based on materials provided by Ohio State University Medical Center. Note: Materials may be edited for content and length.


Cite This Page:

Ohio State University Medical Center. "Updated clinical results show experimental agent ibrutinib as highly active in CLL patients." ScienceDaily. ScienceDaily, 8 December 2012. <www.sciencedaily.com/releases/2012/12/121208122709.htm>.
Ohio State University Medical Center. (2012, December 8). Updated clinical results show experimental agent ibrutinib as highly active in CLL patients. ScienceDaily. Retrieved July 23, 2014 from www.sciencedaily.com/releases/2012/12/121208122709.htm
Ohio State University Medical Center. "Updated clinical results show experimental agent ibrutinib as highly active in CLL patients." ScienceDaily. www.sciencedaily.com/releases/2012/12/121208122709.htm (accessed July 23, 2014).

Share This




More Health & Medicine News

Wednesday, July 23, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Courts Conflicted Over Healthcare Law

Courts Conflicted Over Healthcare Law

AP (July 22, 2014) — Two federal appeals courts issued conflicting rulings Tuesday on the legality of the federally-run healthcare exchange that operates in 36 states. (July 22) Video provided by AP
Powered by NewsLook.com
Why Do People Believe We Only Use 10 Percent Of Our Brains?

Why Do People Believe We Only Use 10 Percent Of Our Brains?

Newsy (July 22, 2014) — The new sci-fi thriller "Lucy" is making people question whether we really use all our brainpower. But, as scientists have insisted for years, we do. Video provided by Newsy
Powered by NewsLook.com
Scientists Find New Way To Make Human Platelets

Scientists Find New Way To Make Human Platelets

Newsy (July 22, 2014) — Boston scientists have discovered a new way to create fully functioning human platelets using a bioreactor and human stem cells. Video provided by Newsy
Powered by NewsLook.com
Gilead's $1000-a-Pill Drug Could Cure Hep C in HIV-Positive People

Gilead's $1000-a-Pill Drug Could Cure Hep C in HIV-Positive People

TheStreet (July 21, 2014) — New research shows Gilead Science's drug Sovaldi helps in curing hepatitis C in those who suffer from HIV. In a medical study, the combination of Gilead's Hep C drug with anti-viral drug Ribavirin cured 76% of HIV-positive patients suffering from the most common hepatitis C strain. Hepatitis C and related complications have been a top cause of death in HIV-positive patients. Typical medication used to treat the disease, including interferon proteins, tended to react badly with HIV drugs. However, Sovaldi's %1,000-a-pill price tag could limit the number of patients able to access the treatment. TheStreet's Keris Lahiff reports from New York. Video provided by TheStreet
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
 
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:  

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:  

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile iPhone Android Web
Follow Facebook Twitter Google+
Subscribe RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins