Venclexta + Gazyva Improves Chronic Lymphocytic Leukemia Outcomes

CLL 14 Clinical trial establishes Venclexta-Gazyva combo as "standard of care" for treatment of newly diagnosed CLL

​Venclexta + Gazyva Improves Chronic Lymphocytic Leukemia Outcomes

by Dr. C.H. Weaver M.D. 10/31/2018

Results of the phase III “CLL14” study comparing Venclexta® (venetoclax) in combination with Gazyva® (obinutuzumab) to standard treatment with Gazyva plus chlorambucil were released and show that the Venclexta combination reduces the risk of leukemia progression or death compared to the previous standard-of-care Gazyva plus chlorambucil.

About Chronic Lymphocytic Leukemia (CLL)

Chronic lymphocytic leukemia (CLL) is the most common form of adult leukemia. The American Cancer Society estimates that approximately 20,000 people will be diagnosed and 4,580 will die from CLL this year. Currently, there are approximately 95,000 people in the United States living with CLL.

CLL is characterized by the production of atypical lymphocytes. Lymphocytes are specialized immune cells that exist in two forms: B- and T-cells. These cells are produced in the bone marrow and each serves a specific function in aiding the body to fight infection. The large majority of CLL cases involve mature B-lymphocytes that tend to live much longer than normal. B-lymphocytes accumulate in the blood, bone marrow, lymph nodes, and spleen. This results in overcrowding of these areas and suppression of the formation and function of blood and immune cells. Additionally, the cancerous lymphocytes themselves do not function normally, leading to a further reduction in the body’s ability to fight infection. The disease tends to get worse slowly.

About Venclexta

The BCL-2 protein is a type of protein that contributes to a cancer cell’s survival. Over expression of the BCL-2 protein in lymphoma and leukemia cells is associated with increased survival time of the cancer cells as well as resistance to standard chemotherapy. Venclexta is a small molecule that selectively binds to the BCL-2 protein, thereby disabling its ability to keep cancer cells alive.

Venclexta is used to treat people with CLL or small lymphocytic lymphoma (SLL), with or without the 17p deletion, who have received at least one prior treatment.

About Gazyva

Gazyva® (obinutuzumab) is an engineered monoclonal antibody designed to attach to CD20, a protein found only on B-cells. It attacks targeted cells both directly and together with the body's immune system. Gazyva is used in combination with the chemotherapy drug, chlorambucil, to previously untreated CLL, and for use with bendamustine for follicular lymphoma (FL) in adults who did not respond to a rituximab-containing regimen, or whose FL returned after such treatment.

About the CLL14 Study

Researchers theorized that the combination of two precision cancer medicines aimed at different targets on CLL cells (BCL-2 and CD20) should improve outcomes compared to either alone or combined with chemotherapy.

The CLL14 is a clinical trial directly compared the combination of Venclexta plus Gazyva compared to Gazyva plus chlorambucil in 432 patients with previously untreated CLL. Results of the trial demostrated that the Venclexta-Gazyva combination delayed cancer progression and reduced the risk of dying compared to the standard Gazyva-chlorambucil combination. The full results of the CLL14 clinical trial will be released at an upcoming medical meeting but suggest the Venclexta-Gazyva will become the new standard of care for newly diagnosed CLL patients.