Featured Research

from universities, journals, and other organizations

Ibrutinib as second-line therapy for chronic lymphocytic leukemia supported by study

Date:
May 31, 2014
Source:
Ohio State University Wexner Medical Center
Summary:
In a head-to-head comparison of two Food and Drug Administration-approved drugs for the treatment of relapsed chronic lymphocytic leukemia, ibrutinib significantly outperformed ofatumumab as a second-line therapy, according to a multicenter interim study. Ibrutinib is the first drug designed to target Bruton's tyrosine kinase, a protein essential for CLL-cell survival and proliferation.

In a head-to-head comparison of two Food and Drug Administration-approved drugs for the treatment of relapsed chronic lymphocytic leukemia (CLL), ibrutinib significantly outperformed ofatumumab as a second-line therapy, according to a multicenter interim study published in the OnLine First edition of the New England Journal of Medicine. Ibrutinib (Imbruvica) is the first drug designed to target Bruton's tyrosine kinase (BTK), a protein essential for CLL-cell survival and proliferation. CLL, the most common form of leukemia, causes a gradual increase in white blood cells called B lymphocytes, or B cells. The National Cancer Institute estimates that 15,680 Americans ​were diagnosed with CLL and 4,580 died from the disease in 2013.

In the current phase 3 trial, patients were randomized to receive once-a-day oral ibrutinib or the anti-CD20 antibody ofatumumab, a drug considered part of the current standard of care for CLL.

Of the 391 patients enrolled to the phase 3 study, 195 were randomized to ibrutinib and 196 to ofatumumab. Median follow-up was 9.4 months and showed that ibrutinib significantly lengthened progression-free survival as a second-line therapy for CLL before anything else is used.

"At median follow-up, 86 percent of patients on ibrutinib had durable response and were continuing treatment with minimal side effects. This is remarkable, especially considering that standard CLL therapies typically produce a 35-40 percent response rate," says John C. Byrd, MD, principal investigator of the study and hematology division director at The Ohio State University Comprehensive Cancer Center -- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC -- James.)

At six months, 83 percent of patients treated with ibrutinib experienced progression-free survival compared to 49 percent of patients on ofatumumab.

"Ibrutinib significantly prolonged progression-free survival, resulting in a 78 percent reduction in the risk of disease progression or death in patients treated with ibrutinib compared with ofatumumab," adds Byrd. "We observed similar progression-free survival results regardless of age, clinical stage or unique factors such as genetic mutation status."

In 2013, Byrd and his team reported findings from a phase 1b/2 study of 85 patients with relapsed CLL patients on ibrutinib in the New England Journal of Medicine.Based on positive early response rates, the Data Monitoring Committee recommended patients be given option to switch to the ibrutinib arm of the study. At that time, 29 percent of patients with confirmed disease progression on ofatumumab crossed over to the ibrutinib arm of the study.

At 12 months, the overall survival rate among patients treated with ibrutinib was 90 percent compared to 81 percent in ofatumumab arm.Additionally, 43 percent of patients on ibrutinib achieved partial response to treatment compared with just 4 percent of patients receiving ofatumumab.

"There is no question that ibrutinib far outperforms existing therapies we have for CLL, and we're excited to see this drug improving the outcome for patients who were once considered incurable," says Byrd.

Phase 3 studies are currently underway at The OSUCCC -- James and affiliated cancer centers to determine whether ibrutinib is effective as a first-line therapy in CLL, and in other blood cancer treatment challenges such as reducing graft versus host disease in bone marrow transplant patients.


Story Source:

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


Journal Reference:

  1. John C. Byrd, Jennifer R. Brown, Susan O'Brien, Jacqueline C. Barrientos, Neil E. Kay, Nishitha M. Reddy, Steven Coutre, Constantine S. Tam, Stephen P. Mulligan, Ulrich Jaeger, Steve Devereux, Paul M. Barr, Richard R. Furman, Thomas J. Kipps, Florence Cymbalista, Christopher Pocock, Patrick Thornton, Federico Caligaris-Cappio, Tadeusz Robak, Julio Delgado, Stephen J. Schuster, Marco Montillo, Anna Schuh, Sven de Vos, Devinder Gill, Adrian Bloor, Claire Dearden, Carol Moreno, Jeffrey J. Jones, Alvina D. Chu, Maria Fardis, Jesse McGreivy, Fong Clow, Danelle F. James, Peter Hillmen. Ibrutinib versus Ofatumumab in Previously Treated Chronic Lymphoid Leukemia. New England Journal of Medicine, 2014; 140531043010008 DOI: 10.1056/NEJMoa1400376

Cite This Page:

Ohio State University Wexner Medical Center. "Ibrutinib as second-line therapy for chronic lymphocytic leukemia supported by study." ScienceDaily. ScienceDaily, 31 May 2014. <www.sciencedaily.com/releases/2014/05/140531090722.htm>.
Ohio State University Wexner Medical Center. (2014, May 31). Ibrutinib as second-line therapy for chronic lymphocytic leukemia supported by study. ScienceDaily. Retrieved October 21, 2014 from www.sciencedaily.com/releases/2014/05/140531090722.htm
Ohio State University Wexner Medical Center. "Ibrutinib as second-line therapy for chronic lymphocytic leukemia supported by study." ScienceDaily. www.sciencedaily.com/releases/2014/05/140531090722.htm (accessed October 21, 2014).

Share This



More Health & Medicine News

Tuesday, October 21, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

CDC Revamps Ebola Guidelines After Criticism

CDC Revamps Ebola Guidelines After Criticism

Newsy (Oct. 21, 2014) The Centers for Disease Control and Prevention have issued new protocols for healthcare workers interacting with Ebola patients. Video provided by Newsy
Powered by NewsLook.com
First-Of-Its-Kind Treatment Gives Man Ability To Walk Again

First-Of-Its-Kind Treatment Gives Man Ability To Walk Again

Newsy (Oct. 21, 2014) A medical team has for the first time given a man the ability to walk again after transplanting cells from his brain onto his severed spinal cord. Video provided by Newsy
Powered by NewsLook.com
CDC Issues New Ebola Guidelines for Health Workers

CDC Issues New Ebola Guidelines for Health Workers

Reuters - US Online Video (Oct. 21, 2014) The U.S. Centers for Disease Control and Prevention has set up new guidelines for health workers taking care of patients infected with Ebola. Linda So reports. Video provided by Reuters
Powered by NewsLook.com
'Cadaver Dog' Sniffs out Human Remains

'Cadaver Dog' Sniffs out Human Remains

AP (Oct. 21, 2014) Where's a body buried? Buster's nose can often tell you. He's a cadaver dog, specially trained to find human remains and increasingly being used by law enforcement and accepted in courts. These dogs are helping solve even decades-old mysteries. (Oct. 21) Video provided by AP
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:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

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