Arzerra, Fludara, and Cytoxan Promising for Previously Untreated CLL

The combination of Arzerra™ (ofatumumab), Fludara® (fludarabine), and Cytoxan® (cyclophosphamide) shows promising effectiveness in the initial treatment of chronic lymphocytic leukemia (CLL). These results were presented at the 2009 annual meeting of the American Society of Hematology.

Chronic lymphocytic leukemia (CLL) is the most common form of adult leukemia. The American Cancer Society estimates that approximately 15,000 people will be diagnosed with 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 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.

Arzerra targets a molecule known as CD20, which is found on the surface of B-cells. It has been shown to produce responses in patients with CLL that is refractory to Fludara and Campath® (alemtuzumab).

To evaluate a combination of Arzerra, Fludara, and Cytoxan in patients with previously untreated CLL, researchers conducted a Phase II clinical trial among 61 patients.

Half the patients received a 500 mg dose of Arzerra and half received a 1,000 mg dose of Arzerra in combination with standard doses of Fludara and Cytoxan.

  • The complete response rate was 32% for the 500 mg dose of Arzerra and 50% for the 1,000 mg dose.
  • The overall response rate was 77% for the 500 mg dose of Arzerra and 73% for the 1,000 mg dose.
  • Toxicities were described as expected and tolerable.

These results suggest that the combination of Arzerra, Fludara, and Cytoxan is active against previously untreated CLL. The 1,000 mg dose of Arzerra is being further evaluated in other studies.

Reference: Wierda WG, Kipps TJ, Durig J, et al. Ofatumumab combined with fludarabine and cyclophosphamide (O-FC) shows high activity in patients with previously untreated chronic lymphocytic leukemia (CLL): Results from a randomized, multicenter, international, two-dose, parallel group, phase II trial. Blood. 2009;114:90 abstract 207.

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