Navigation Links
Ibrutinib has 'unprecedented' impact on mantle cell lymphoma
Date:12/14/2012

ATLANTA - An international study of ibrutinib in people with relapsed or refractory mantle cell lymphoma (MCL) continues to show unprecedented and durable results with few side effects.

Researchers from The University of Texas MD Anderson Cancer Center presented interim findings of the multi-center Phase 2 study today at the 54th American Society of Hematology Annual Meeting and Exposition.

"I believe we are witnessing a breakthrough in mantle cell lymphoma. This is great news for patients," said Michael Wang, M.D., associate professor in MD Anderson's Departments of Lymphoma and Myeloma and Stem Cell Transplantation and Cellular Therapy. Wang is lead author of the study.

Wang, director of the mantle cell lymphoma (MCL) program at MD Anderson, has spent the past 12 years researching the disease, including clinical trials of proteasome inhibitors, immune-modulating agents and an mTOR inhibitor.

"In a heavily treated relapsed or refractory population, oral ibrutinib induced a response rate as high as 70 percent - better than any other single agent ever tested in MCL," he said. "The response is durable with a long progression-free survival. "

Dangerous disease presents treatment challenges

MCL is a rare and aggressive B-cell subtype of non-Hodgkin lymphoma that, according to the Leukemia and Lymphoma Society, accounts for 6 percent of non-Hodgkin cases. Despite high response rates to initial combination-drug chemotherapy, which is highly toxic, patients often relapse.

Bruton's tyrosine kinase is a mediator of B cell receptor signaling, which is essential for normal B-cell development. Ibrutinib inhibits Bruton's tyrosine kinase (BTK), causing cell death and decreasing cellular migration and adhesion in malignant B-cells.

"The foundation for this clinical success is based on biology," Wang said. "The B-cell receptor pathway is critical in B-cell lymphoma. BTK is the driver molecule in this pathway, and ibrutinib targets the BTK molecule."

Oral medication

Preliminary results reported at ASH in 2011 included 51 patients and demonstrated ibrutinib can achieve rapid response, including complete response, in relapsed and resistant MCL.

To date, 115 people have enrolled in the study. Of these patients, 110 were evaluated for the drug's efficacy. Patients had a median age of 68 years, time since diagnosis of 42 months, three prior treatments and 77 percent had stage 4 disease.

Ibrutinib was given orally at 560 mg daily in continuous 28-day cycles until disease progression.

Strong results, low toxicity

With a median follow-up period of 9.2 months, overall response rate was 68 percent, and complete remission rate was 22 percent.

Responses increased with longer time on study treatment:

  • Median time to partial response was two months
  • Median time to complete remission was four months
  • Median time on treatment was six months
  • 53 percent of subjects remain on treatment

Response was even more dramatic in the 51 original patients with:

  • Overall response rate of 75 percent
  • Complete remissions in 39 percent
  • Median time on study treatment 15 months

"What impressed me the most is the high complete remission rate, which continues to improve with time, and yet it is the safest drug we have for mantle cell lymphoma," Wang said. "Previously such a rate could be achieved only with combination cyto-reductive chemotherapy, which is bone marrow suppressive and toxic."

Most side effects were minor and included diarrhea, fatigue, upper respiratory tract infections, nausea and rash. Grade 3 or higher effects included low white cell blood counts, anemia and diarrhea. One case of pneumonia was thought to be treatment-related. This was consistent with safety data previously reported, Wang said.

A pivotal study in relapsed and refractory MCL patients following bortezomib treatment has begun.


'/>"/>

Contact: Scott Merville
smerville@mdanderson.org
713-792-0661
University of Texas M. D. Anderson Cancer Center
Source:Eurekalert  

Related medicine news :

1. Updated Clinical Results Show Experimental Agent Ibrutinib as Highly Active in CLL Patients
2. Unprecedented accuracy in locating brain electrical activity with new device
3. UT MD Anderson Cancer Center launches unprecedented Moon Shots Program
4. Autism by the numbers: Yale researchers examine impact of new diagnostic criteria
5. Social ties have mixed impact on encouraging healthy behaviors in low-income areas
6. Pediatric epilepsy impacts sleep for the child and parents
7. Dartmouth researchers investigate the cognitive effects of athlete head impacts
8. Comprehensive report documents impact of urologic diseases on American public
9. New federal disclosure law may have little impact on drugs prescribed
10. After 25 years, World No Tobacco Day is making an impact
11. Sleep apnea persisting into teens can impact life skills, study finds
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Ibrutinib has 'unprecedented' impact on mantle cell lymphoma
(Date:1/24/2017)... ... ... “Mysteries Revealed On Speaking In Tongues”: an engaging and dynamic study ... “Mysteries Revealed On Speaking In Tongues” is the creation of published author, Tina Jackson, ... in Michigan. , “We need to partner with Jesus and be the voice ...
(Date:1/24/2017)... ... January 24, 2017 , ... HealthCarePoint ... survivors, today announced formation of its first global advisory board to help ... , Like HCP founders, the global advisory board is composed of key ...
(Date:1/24/2017)... ... January 23, 2017 , ... CLICKco LLC, a company known ... its CLICK® Coffee Protein Drink is now available for purchase on RevNutrition.com, a ... popular among health-conscious consumers who love coffee but are looking to add more ...
(Date:1/24/2017)... ... January 23, 2017 , ... OSF Ventures, ... the world’s largest start-up platform headquartered in Silicon Valley that connects startups to ... Ventures recently signed a three-year agreement to be a corporate sponsor of Plug ...
(Date:1/24/2017)... ... 2017 , ... The January 2017 issue of the Journal of Counseling & ... behavioral healthcare (OBH) – also known as wilderness therapy – helped a group of ... sense of purpose both during and after treatment. , The study was published ...
Breaking Medicine News(10 mins):
(Date:1/24/2017)... Jan 24, 2017 Research and Markets has ... - Sensor, Actuator - Forecast to 2025" report to their ... Global ... 17.6% over the next decade to reach approximately $76.24 million by ... is witnessing include growing count of labs using optogentic techniques for ...
(Date:1/24/2017)... , January 24, 2017 ... dem Molecular Surgical Laboratory des Massachusetts General Hospital (MGH) ... Dabei geht es um die Identifizierung und Validierung neuartiger ... Ansätzen, dass sie der Resistenz von Antibiotika bei der ... ...
(Date:1/24/2017)... -- Scope of the Report The report titled ... Market (2016-2020)", provides an in-depth analysis of the global ... line. The market also provides an in-depth analysis of ... a regional analysis of continence care market, including the ... Europe and Rest of the World. ...
Breaking Medicine Technology: