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Title: Alemtuzumab Appears Promising as First-Line B-Cell Chronic Lymphocytic Leukemia Treatment: Presented at ASH

"Alemtuzumab Appears Promising as First-Line B-Cell Chronic Lymphocytic Leukemia Treatment: Presented at ASH"

By Bruce Sylvester ORLANDO, FL -- December 11, 2006 -- Previously untreated patients with B-cell chronic lymphocytic leukemia (B-CLL) achieve a significant 42% reduction in progression-free survival when they are treated with alemtuzumab (Campath) compared with patients who are treated with chlorambucil, investigators reported here at the American Society of Hematology 48[^th Annual Meeting and Exposition (ASH).

"Used as a single agent, Campath produced the highest response rate of any single agent in CLL seen in any front-line trial," said lead investigator Peter Hillmen, MD, PhD, program chair, department of clinical hematology and hematological malignancy diagnostic service, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.

Researchers in the phase 3, open-label, randomized trial enrolled 297 previously untreated B-CLL patients. They randomized 149 subjects to receive Campath 30 mg IV 3 times per week for up to 12 weeks and 148 to chlorambucil 40 mg/m² by mouth every 28 days for up to 12 cycles.

Patients who received Campath for a median of 12 weeks achieved significantly higher overall and complete response rates compared with the chlorambucil subjects, who were treated for a median of 24 weeks. The researchers reported a nearly 30% superior overall response rate (ORR) for Campath (83% vs 55%, P < .0001) and a 12-fold advantage in complete remission rates for Campath patients (24% vs 2%, P < .0001).

Tolerability for Campath was predictable and manageable, with grade 3/4 neutropenia, leucopenia, and lymphopenia appearing at a higher rate in the Campath arm. There were no significant differences between Campath and chlorambucil for febrile neutropenia or grade 3/4 thrombocytopenia and anemia. No treatment-related deaths occurred in the Campath cohort, and 1 treatment-related death occurred in the chlorambucil cohort.

Campath received accelerated approval from the US Food and Drug Administration (FDA) in 2001. Campath is FDA-approved for the treatment of B-cell chronic lymphocytic leukemia in patients who have been treated with alkylating agents and who have failed fludarabine therapy.

The study reported on December 11^th is the primary postapproval commitment study designed to support the 2001 accelerated approval.

"This trial encourages us to explore the use of Campath earlier in treatment of the disease," Dr. Hillmen added.

[Presentation title: Alemtuzumab (Campath, MabCampath) Has Superior Progression Free Survival (PFS) Vs Chlorambucil as Front-Line Therapy for Patients With Progressive B-Cell Chronic Lymphocytic Leukemia (BCLL). Abstract 301]

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