The Leukemia & Lymphoma Society Applauds Encouraging Data From a Phase 2 Study of Venetoclax for a High-Risk Subset of Chronic Lymphocytic Leukemia Patients

WHITE PLAINS, N.Y., Aug. 19, 2015 /PRNewswire-USNewswire/ -- The Leukemia & Lymphoma Society (LLS) welcomes the news that an investigational therapy to treat patients with a high-risk subset of chronic lymphocytic leukemia (CLL) has shown very positive results in a Phase II clinical trial.

There are more than 126,000 patients in the United States currently living with CLL, a typically slow-moving blood cancer that begins in the bone marrow.  Of those CLL patients who do not respond to therapy, or who have relapsed, approximately 30% are found to have a mutation in which they are missing part of chromosome 17.

Genentech and AbbVie announced that a statistically significant percentage of patients in the clinical trial, all of whom harbored this 17p deletion, responded to the therapy, venetoclax, formerly known as ABT-199. The results showed they had a clinically meaningful reduction in the number of their cancer cells. More details on the data will be released at upcoming cancer conferences.

The announcement is the latest encouraging news for patients with CLL, who have, until recently, experienced little change in the standard of care for several decades. In just the past two years  there has been an explosion of new treatment options for CLL patients, including targeted therapies such as ibrutinib, idelalisib, obinutuzumab and CAR-T immunotherapy, most of which have been supported by LLS funding.  LLS has supported the research for venetoclax as well.

"We have seen remarkable advances in treatments for patients with CLL over the past two years," said Louis J. DeGennaro, LLS's president and CEO.  "This therapy, in particular, is targeting a rare subset of patients with CLL who have a very poor prognosis and we are hopeful that these results will ultimately lead to a new drug approval. It is gratifying to see work we have supported for so many years finally yielding positive outcomes for patients who desperately need new options."

Since 2002, LLS has continuously supported research helping to advance this therapy. The work supported by LLS was conducted through a major collaboration led by Jerry Adams, Ph.D., at Walter and Eliza Hall Institute of Medical Research in Melbourne, Australia. Clinical trials of venetoclax have been conducted under the leadership of Andrew Roberts, MB, MS, Ph.D., a member of Dr. Adams's Specialized Center of Research (SCOR) team.

The SCOR grant is a $6.25 million award given over five years; it is the largest grant in the LLS portfolio designed to encourage interdisciplinary, ground-breaking research leading to new therapies.  Dr. Adams's group has received three SCOR awards over 15 years, emphasizing LLS's long-term commitment to advance critical new therapies that begin at the bench and achieve success in the clinic. LLS's SCOR grants have also supported the advancement of other newly approved therapies for CLL.

Venetoclax works by targeting the BCL-2 protein. This protein plays a pivotal role in a process called apoptosis, which governs the process of programmed cell death. When the apoptosis machinery is not working properly, malignant cells can proliferate.

Phase 1, 2 and 3 clinical trials for venetoclax are ongoing, both as a monotherapy and in combination with other therapies, and data will be presented to the U.S. Food and Drug Administration (FDA) and other health authorities around the world for approval consideration. The FDA has granted Breakthrough Therapy Designation for venetoclax for treatment of previously treated CLL patients with the 17p deletion. The designation is meant to expedite the development and review of medicines intended to treat serious diseases.

About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society ® (LLS) is the world's largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, multiple myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care.

Founded in 1949 and headquartered in White Plains, NY, LLS has chapters throughout the United States and Canada. To learn more, visit www.LLS.org. Patients should contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m. ET.

Contact: Andrea Greif
Tel: (914) 821-8958
Cell: (914) 772-3027
andrea.greif@lls.org

SOURCE The Leukemia & Lymphoma Society