GENZYME, BERLEX PRESENT RESULTS FROM LEUKEMIA TRIAL

Genzyme and Berlex, a U.S. affiliate of Schering AG, have announced results from CAM307, an international, Phase III clinical trial comparing Campath (alemtuzumab) with chlorambucil in previously untreated patients with B-cell chronic lymphocytic leukemia (B-CLL). The study data were presented at a meeting of the American Society of Hematology.

The international open-label, randomized trial in 297 patients compared the efficacy and safety of Campath to chlorambucil, which is considered by many to offer the most tolerable safety profile among agents commonly used for previously untreated B-CLL patients. The study examined a primary endpoint of progression-free survival and secondary endpoints that included safety, response rate, response duration, time to alternative treatment, and overall survival.

The study met its primary endpoint by demonstrating superior progression-free survival in patients treated with Campath versus chlorambucil, with Campath reducing the risk of disease progression or death by 42 percent.

Secondary endpoint analyses showed that patients who received Campath for a median of nearly 12 weeks exhibited significantly higher overall and complete response rates, with a manageable safety profile, compared with those patients who were treated with chlorambucil for a median of 24 weeks. The data showed a nearly 30 percent greater overall response rate among patients treated with Campath that in those receiving chlorambucil

Campath received accelerated approval in 2001, and CAM307 was the primary postapproval commitment study designed to support full approval. Campath is currently indicated for the treatment of B-CLL in patients who have been treated with alkylating agents and who have failed fludarabine therapy.