Ibrutinib Granted Third Breakthrough Status for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)

On April 8, the FDA granted a third Breakthrough Therapy Designation for the investigational agent ibrutinib. Previously, receiving breakthrough status for the treatment of patients with Waldenström’s macroglobulinemia and mantle cell lymphoma, the drug has now achieved breakthrough status as a monotherapy for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in patients with deletion of the short arm of chromosome 17 (deletion 17p). This is an especially important development as CLL and SLL affected carriers of the deletion of chromosome 17 mutation are prone to poor prognoses, often due to their poor responses to chemoimmunotherapy.

Ibrutinib, an oral drug designed to specifically target an enzyme called Bruton’s tyrosine kinase (BTK), has demonstrated promising activity in multiple phase 1 and 2 clinical trials performed at Weill Cornell Medical College and around the world. As one of the leading institutions in the study of ibrutinib since its first testing 3 years ago, Weill Cornell is uniquely positioned in its experience with ibrutinib.

Currently, there are ongoing ibrutinib clinical trials at the Weill Cornell Lymphoma Program open to patients with CLL and SLL. Additional clinical trials for Waldenström’s macroglobulinemia and mantle cell lymphoma with ibrutinib are ongoing.

Please stay updated with our clinical trials listing for forthcoming trials involving ibrutinib and the Cornell Lymphoma Program website for further clinical research updates.

Rally for Medical Research: Help Protect Funding for Medical Research

On April 8, 2012 thousands of individuals and nearly 200 partnering programs, including representatives from the American Society of Hematology (ASH), American Society of Clinical Oncology (ASCO), and American Association of Cancer Research (AACR) gathered at the Carnegie Library grounds in Washington, D.C. for the Rally for Medical Research. Here medical research supporters sought to raise public awareness over the importance of federally funded medical research. This need has been magnified by the March 1 sequestration mandated cuts to all areas of the federal budget, and a decade long decline in funding for the National Institute of Health (NIH).

As ASH wrote, this decline in money for medical research is not a new development:

“Research supported by the National Institutes of Health (NIH) is in serious jeopardy. NIH’s inflation-adjusted budget today is almost 20 percent lower than it was in FY 2003…Under sequestration, the NIH budget will be cut by an additional $1.6 billion over the remainder of fiscal year (FY) 2013. While the impact of these cuts may not be felt all at once or immediately, the harm caused to bio-medical research will be devastating- progress toward cures for deadly diseases and efforts to prevent costly chronic conditions will be slowed…”

Besides these  budgetary concerns, ASCO President Sandra M. Swain noted the human cost of such budget cuts, stressing the impressive strides made in cancer research due to federal funding:

“As a direct result of the federal investment in cancer research, we understand more about cancers than at any point in human history. This understanding of cancer at the molecular level has created unprecedented opportunities to slow the growth of cancer diseases. As a country, we can be proud that two of three people in the U.S. with cancer live at least 5 years after their diagnosis. This is up from one of two in the 1970s before the passage of the National Cancer Act. Since the 1990s, the nation’s cancer death rate has dropped 18 percent, reversing decades of increases. More than 13 million people in the U.S. are cancer survivors.”

Considering these new fiscal realities, the researchers and clinicians in the Lymphoma Program at Weill Cornell Medical College are adjusting accordingly. They will continue to do all that they can to deliver the latest in ground breaking research and clinical care.

Click here to use the ASH advocacy tool to contact your Representative and Senators about protecting medical research. Contact information for individual Representatives and Senators can be found here and here.

Weill Cornell Breakthrough Research: Shutting Down DLBCL Master Protein; Potential for New Treatments

Reporting in Nature Immunology, Weill Cornell’s Dr. Ari Melnick and his research team have reported an important research breakthrough in diffuse large-B cell lymphoma (DLBCL) that may offer hope for new treatments for aggressive lymphomas.

Dr. Melnick has found that it is possible to shut down the protein Bcl6, a powerful master regulatory transcription factor that is the key to survival for many aggressive lymphomas arising from the B-cells.

“The finding comes as a very welcome surprise,” says the study’s lead investigator, Dr. Ari Melnick, Gebroe Family Professor of Hematology/Oncology and director of the Raymond and Beverly Sackler Center for Biomedical and Physical Sciences at Weill Cornell.

The protein Bcl6 was previously considered too complex to target with individual drugs, because of its centrality in the functioning of the body’s healthy immune cells.

“This means the drugs we have developed against Bcl6 are more likely to be significantly less toxic and safer for patients with this cancer than we realized,” says Dr. Melnick.

DLBCL is the most common subtype of non-Hodgkin lymphoma — the seventh most frequently diagnosed cancer, with many patients resistant to currently available treatments. Presently, there are ongoing clinical trials for those suffering from non-Hodgkin’s lymphoma and other forms of lymphoma at the Weill Cornell Lymphoma Center.

The full press release can be read here.