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Final Data from Phase III Study Show Single-Agent Alemtuzumab (MabCampath(R)) Superior to Chlorambucil for Patients with Previously Untreated B-CLL.

LEEDS, England, December 12 /PRNewswire/ --

Patients with B-cell chronic lymphocytic leukemia (B-CLL) may soon have a more effective treatment option earlier in the course of their disease, according to final data from the CAM 307 international Phase III study presented at the 48th Annual Meeting of the American Society of Hematology.(1) These data showed alemtuzumab (MabCampath(R)) was superior to chlorambucil as a first-line therapy with respect to progression free survival (PFS) in previously untreated patients with B-CLL. Patients receiving alemtuzumab also exhibited higher overall and complete response rates with a manageable safety profile, compared to patients who were treated with chlorambucil.

(Logo: http://www.newscom.com/cgi-bin/prnh/20061212/NYTU048LOGO )

"This study demonstrates that alemtuzumab is superior as a first-line therapy compared to chlorambucil," stated lead investigator Peter Hillmen, M.B., Ch.B, Consultant Haematologist, Leeds General Infirmary, Leeds, United Kingdom.

Results from the open-label, randomized trial showed that alemtuzumab demonstrated a superior PFS versus chlorambucil (p = 0.0001), meeting the study's primary endpoint, and the risk of progression or death was reduced by 42 percent with alemtuzumab versus chlorambucil (p=0.0001). Of the 297 patients in the study, the overall response rate (ORR) for alemtuzumab was 83 percent versus 55 percent for chlorambucil (p < 0.0001), which represents a nearly 30 percent greater ORR with alemtuzumab. The complete response rate (CRR) was 24 percent for alemtuzumab versus two percent for chlorambucil (p < 0.0001), representing a 12-fold higher CRR with alemtuzumab. Chlorambucil is a chemotherapy drug that has been used extensively in first-line treatment of B-CLL.

"We are very encouraged by the activity and safety of alemtuzumab as a single-agent for the treatment of CLL. This study encourages us to fully explore the potential of alemtuzumab in combination and consolidation therapies," said Dr. Hillmen.

Nine of a total of 34 complete responder patients receiving alemtuzumab achieved a minimal residual disease (MRD) negative response, as defined by testing below the level of B-CLL detection. Eight out of these nine MRD negative patients demonstrated a sustainable response showing no disease progression at a median follow-up of two years following treatment. The goal of MRD negativity was not achieved for any of the three patients reaching a complete response with chlorambucil. Studies suggest that aiming to reduce MRD below any detectable level is achievable and associated with prolonged treatment-free and overall survival.

There were no significant differences observed in grade 3/4 thrombocytopenia (the presence of relatively few platelets in blood), anemia (a deficiency of red blood cells and/or hemoglobin) or febrile neutropenia (a condition in which patients have a fever and a low white blood cell count). Statistically significant differences in the rates of grade 3/4 neutropenia (a condition characterized by an abnormally low number of a type of white blood cell known as neutrophil granulocytes), between the alemtuzumab and chlorambucil patient groups were reported.

Among patients receiving alemtuzumab, the most common grade 3/4 treatment-related adverse events were infusion-related reactions associated with intravenous administration, including fevers and chills. Symptomatic CMV reactivation developed in only 16 percent of patients and was managed with antiviral therapy. There were no treatment-related deaths among patients receiving alemtuzumab, while one treatment-related death occurred in a patient receiving chlorambucil.

About This Study

The open-label trial randomized 297 patients with previously untreated, progressive disease requiring treatment at 44 medical centers in Europe and the United States. Patients were treated with either 30 mg of alemtuzumab IV three times per week for a maximum of 12 weeks, inclusive of dose escalation periods, or 40 mg/m2 of chlorambucil PO once every 28 days to a maximum of 12 cycles.

Progression-free survival was the primary endpoint, and secondary endpoints included safety, overall and complete response rates, and overall survival.

The study was sponsored by Genzyme Corporation and Schering AG. Leeds General Infirmary was a CAM 307 clinical trial site.

About CLL

CLL is a type of cancer in which the bone marrow manufactures too many lymphocytes (a type of white blood cell). Symptoms include enlarged lymph nodes, liver or spleen, fatigue, abnormal bruising, excessive sweating, loss of appetite, and weight loss. Patients are also susceptible to weakening of the immune system, exposing the patient to a higher risk of infection. CLL affects about 120,000 people in Europe and the US and is the most prevalent form of adult leukemia. The disease often occurs during or after middle age; it hardly ever occurs in children. In CLL, too many functionally immature white blood cells (lymphocytes) accumulate in the bone marrow, blood, lymph tissue, and other organs. There are two types of lymphocytes 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, leaving less room for healthy white blood cells, red blood cells, and platelets. The accumulation of functionally immature cells in the bone marrow excludes the generation of healthy cells and can become fatal.

 References:

 1. Hillmen et al. Alemtuzumab (CAMPATH(R), MABCAMPATH(R)) Has Superior
 Progression Free Survival (PFS) vs. Chlorambucil as Front-Line Therapy
 for Patients with Progressive B-Cell Chronic Lymphocytic Leukemia
 (B-CLL)), Presented at the 48th Annual Meeting of the American Society
 of Hematology 2006. Abstract #301.



Greg Moulds, Head of Media Relations of Leeds Teaching Hospitals, +44-113-2066244 / Photo: http://www.newscom.com/cgi-bin/prnh/20061212/NYTU048LOGO, AP Archive: http://photoarchive.ap.org, PRN Photo Desk, photodesk@prnewswire.com
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