Promising Activity of Imbruvica Plus Rituxan in High-Risk CLL
Researchers from MD Anderson Cancer Center recently reported in the journal The Lancet Oncology that the combination of Imbruvica® (ibrutinib) and Rituxan® (rituximab) showed promising activity in the management of patients with high-risk chronic lymphocytic leukemia (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.
In this clinical trial, 40 adult patients with high-risk CLL were enrolled and treated with a combination of Imbruvica and Rituxan. High risk was defined as having either a high-risk cytogenetic abnormalities; (deletion 17p, TP53 mutation, or deletion 11q) or shortened time to CLL progression (< 36 months) after initial first-line treatment.
Overall 95% of patients had a response to treatment with Imbruvica and Rituxan and 87% had partial and 8% had complete disappearance of their CLL following treatment. Consistent with previous reports, the treatment was generally well tolerated. Overall 78% of high risk patients treated with the combination of Imbruvica and Rituxan survived without evidence of CLL progression 18-months from treatment.
Imbruvica is one of several newer drugs to show activity in the management of patients with CLL. On February 12, 2014, the U. S. Food and Drug Administration (FDA) granted accelerated approval to Imbruvica for the treatment of patients with CLL who have received at least one prior therapy. Patients have recently benefited from the development of several other drugs including Zydelig (idelalisib), Gazyva (obinutuzumab) and Arzerra (ofatumumab), all of which have been approved by the FDA to treat CLL.
Reference: Burger J, Ketaing M, Wierda W, et al. Safety and activity of ibrutinib plus rituximab for patients with high-risk chronic lymphocytic leukaemia: a single-arm, phase 2 study. The Lancet Oncology, 15;1090 – 1099, September 2014.
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