Campath Meets Primary Endpoint

Genzyme Corporation (GENZ) recently reported positive results from a randomized phase III study that was conducted with Campath (alemtuzumab) in combination with Fludara (fludarabine phosphate) in relapsed or refractory chronic lymphocytic leukemia (CLL) patients. 

The company reported that patients treated with Campath and Fludara (FluCAM) experienced a significant improvement in progression free survival (PFS), compared to patients receiving only Fludara. The study was designed to detect at least a 50% overall improvement in PFS in the FluCAM arm compared to the Fludara arm. 

Although the company did not disclose full results, Genzyme announced that the trial’s independent data safety monitoring board, in a pre-planned interim analysis, determined that the study achieved its primary endpoint and recommended early closure of the trial. 

We look forward to detailed results from the study in December at the American Society of Hematology. Impressive PFS results could help the combination treatment gain share in the CLL market of which Fludara is considered to be the backbone. However, Fludara, which is marketed by Genzyme, faces competition from generic players like Teva Pharmaceuticals (TEVA) among others. Other therapies in the CLL market include Cephalon’s (CEPH) Treanda. 

Genzyme is looking to gain approval for the use of Campath in combination with Fludara in the United States, European Union, and other countries. Campath is currently approved in the United States as a single agent for the treatment of B-CLL, and in the E.U., where it is marketed as MabCampath, for the treatment of patients with B-CLL for whom fludarabine combination chemotherapy is not appropriate. 

Chronic lymphocytic leukemia is the most common type of leukemia in adults, accounting for approximately 25-30% of all forms of leukemia. The approval for combination use would be a major positive for Genzyme and would help boost Campath sales.

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