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Study Results Published in Journal of Clinical Oncology Show FluCam Regimen to Be Highly Effective in Treating Relapsed and Refractory B-Cell Chronic Lymphocytic Leukemia.

COLOGNE, Germany, October 21 /PRNewswire/ --

- Study Demonstrates 83 Percent Overall Response Rate to FluCam Regimen

According to a study published in the October issue of the Journal of Clinical Oncology, combination therapy with MabCampath (alemtuzumab) and Fludara (fludarabine phosphate) (FluCam) is effective in patients with B-CLL who had failed prior intervention, with an overall response rate (ORR) of 83 percent. The newly developed FluCam combination regimen is well tolerated and feasible. Based on these promising results, a prospective, randomized, phase III trial has been initiated comparing FluCam to single agent fludarabine, as second-line therapy for patients with B-CLL.

"When used in combination, Fludara and Campath enhance the benefits seen in monotherapy by attacking the disease both in the blood and bone marrow as well as by reducing massive lymph nodes," said Andreas Engert, M.D., Professor of Internal Medicine at the University Hospital of Cologne, Germany. "The FluCam regimen produces high response rates and long duration of responses in patients who previously had no other options available to them. While survival rates observed in this study show significant improvement over historical controls in a similar patient population, these need to be confirmed in randomised controlled trials."

A total of 36 patients were treated in this phase II study. The ORR was 83 percent, with 11 patients achieving a complete response (CR) and 19 of the patients a partial response (PR). The median overall survival (OS) for all patients was 35.6 months. For the 11 patients achieving a complete remission, median OS has not been reached.

Purine analogs, particularly Fludara, have had a major impact on the management of CLL, achieving overall response rates of 50-60 percent as a single agent in previously treated patients. This analysis demonstrated that with combination therapy, efficacy could be enhanced significantly and that the FluCam combination was effective even in those patients who were refractory to fludarabine.

Study Details

Patients received FluCam therapy after a short period of MabCampath dose escalation from three mg to 10 mg to 30 mg on consecutive days. The FluCam regimen consisted of fludarabine 30 mg/m2/day IV over 15-30 min (Days 1-3) immediately followed by alemtuzumab 30 mg IV over 2 h (Days 1-3). This combination was repeated after 28 days for up to six cycles.

The median age of the patients was 61.47 years (range, 38-80), 75 percent were male, 78 percent had Binet stage C disease, and the median number of prior treatment regimens was two (range, 1-8). The ORR was 83 percent, with 30 percent of the patients achieving a complete response (CR) while 53 percent of the patients achieved a partial response (PR). Fludarabine was the preceding therapy in 22 patients (62 percent) either as a single agent or in combination with other cytotoxic agents or rituximab. Nine (41 percent) of these 22 patients had experienced treatment failure with fludarabine but six of these patients responded to FluCam. CMV (cytomegalovirus) reactivation occurred in only two patients, despite 80 percent being CMV immunoglobulin G-positive at baseline. Notably, seven patients had active autoimmune hemolytic anaemia (AIHA) and/or autoimmune thrombocytopenia (AITP) when entering the trial and were successfully treated with FluCam. Moreover, nine other patients with transfusion-dependent thrombocytopenia and/or anaemia due to bone marrow infiltration prior to therapy were successfully treated and had no need for transfusions after therapy.

About CLL

CLL is the most prevalent form of adult leukemia, annually affecting approximately 120,000 people in the United States and Europe. The disease is most commonly diagnosed in people age 50 or older. CLL is characterized by the accumulation of functionally immature white blood cells (lymphocytes) in the bone marrow, blood, lymph tissue, and other organs. Two types of lymphocytes are present in the blood, B cells and T cells. About 95 percent of CLL cases involve cancerous B cells. Because these B cells have a longer than normal life span, they begin to build up and "crowd out" the normal, healthy blood cells. The accumulation of functionally immature cells in the bone marrow excludes the generation of healthy cells and can become fatal. Symptoms include fatigue, bone pain, night sweats, and decreased appetite and weight loss, but bone marrow involvement also leads to weakening of the immune system, exposing the patient to a higher risk of infection.

About MabCampath(R) (alemtuzumab)

MabCampath, also marketed as Campath(R) in the United States, is the first and only humanized monoclonal antibody approved for CLL and the first drug with proven efficacy in CLL patients who have failed both alkylating agents and Fludara (fludarabine phosphate) treatment. No other therapy has shown comparable efficacy in this group of patients. MabCampath/Campath has a completely different mode of action compared with conventional therapy by selectively targeting the CD52 antigen on the malignant lymphocytes. This activates processes leading to lysis, the death of the malignant cells. These processes result in the removal of the malignant lymphocytes from the bone marrow, blood, and other affected organs, which in turn can lead to an increase in life expectancy.

MabCampath demonstrates a side effect profile that can be safely managed with appropriate prophylaxis against and monitoring for opportunistic infections. These side effects are predictable, manageable and reversible. Furthermore, patients can form their own healthy blood cells once again as MabCampath does not attack the stem cells in the bone marrow.

About Fludara(R) (fludarabine phosphate)

Fludara (fludarabine phosphate) is approved as a first-line and second-line therapy in Europe for the treatment of B-CLL. It also is being investigated as a possible treatment in a variety of cancers and received approval in 2001 from Health Canada for use in the treatment of low-grade non-Hodgkin's lymphoma with more countries following in the meantime.

Fludara is a cytotoxic chemotherapy agent that kills both malignant and nonmalignant white blood cells. Unlike alkylating cytotoxic chemotherapies, which create a toxic environment within the blood to destroy malignant cells, Fludara, a purine nucleoside analog, shortens the life span of existing leukemia cells and interferes with the making of new DNA, thus preventing leukemia cells from growing.

Univ.-Prof. Dr. Andreas Engert, Leitender Oberarzt,, Telefon: +49-221-478-5966/5933, Telefax: +49-221-478-3778, E-Mail:
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Publication:PR Newswire Europe
Date:Oct 21, 2005
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