Positive Data on Genzyme's Campath - Analyst Blog

Genzyme Corp. (GENZ) recently presented encouraging interim results on its oncology product, Campath, at the annual meeting of the American Society of Hematology (ASH). Results from the randomized phase III study (CAM314) showed that Campath, when used in combination with Fludara (FluCAM), significantly reduced the risk of disease progression or death compared to single-agent Fludara in patients with relapsed and refractory chronic lymphocytic leukemia (CLL).
 
Interim results showed that the FluCAM arm demonstrated superior progression free survival (PFS) compared to Fludara alone (29.6 months versus 20.7 months), reducing the risk of disease progression or death by 39%. Importantly, in a pre-specified subgroup of patients with advanced CLL, the median PFS was more than doubled with FluCAM compared to Fludara alone (26.1 months versus 12.1 months).

The FluCAM regimen provided significantly higher overall and complete response rates. The overall response rate of patients on FluCAM was 84.8% compared to 67.9% on Fludara. The complete response rate was 30.4% on FluCAM versus 16.4% on Fludara. FluCAM was also found to have an acceptable safety profile compared to Fludara alone.
 
Genzyme also said that the trial’s independent data safety monitoring board recommended an early closure of the trial as it has achieved its primary endpoint. Final safety and efficacy data should be available in the second half of 2010.
 
The encouraging PFS results on the FluCAM regimen 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. We currently have an Underperform recommendation on Genzyme.

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