CAM314 randomized Phase 3 clinical trial results released

Genzyme Corporation (Nasdaq: GENZ) announced data from its CAM314 randomized Phase 3 clinical trial comparing Campath® (alemtuzumab) in combination with Fludara® (fludarabine phosphate) (FluCAM) to Fludara alone in patients with relapsed and refractory chronic lymphocytic leukemia (CLL) demonstrated that the FluCAM regimen significantly reduced the risk of disease progression or death compared to single-agent Fludara. Importantly, advanced–stage, second-line CLL patients receiving FluCAM more than doubled the amount of time without disease progression in comparison to patients receiving Fludara alone. Data from the study were the subject of an oral presentation today at the 2009 Annual Meeting of the American Society of Hematology (ASH) in New Orleans, LA.

Based on the study’s positive preliminary findings, Genzyme intends to seek regulatory approvals to further broaden the Campath label to include the use of this combination regimen.

Following a planned second interim analysis, the CAM314 trial’s data safety monitoring panel recommended early closure of the study as it had achieved the pre-specified clinical and statistical significance in progression free survival (PFS), the study’s primary endpoint. While patients in the study continue to be followed, and final efficacy and safety data from the study are expected to be available in the second-half of 2010, response data from the second interim analysis (as assessed by the study’s investigators) reported at ASH indicate that the FluCAM combination provided significantly higher overall and complete response rates compared to Fludara alone. The preliminary results also suggest that the FluCAM regimen has an acceptable safety profile when compared to single-agent Fludara.

“The second interim analysis of the CAM314 data showed that the FluCAM regimen may offer significant benefits to patients with chronic lymphocytic leukemia in first relapse,” said study principal investigator and ASH presenter Andreas Engert, MD, Professor of Internal Medicine, Hematology and Oncology, University Hospital of Cologne, Germany. “The FluCAM regimen also had a dosing schedule that was more convenient for patients and physicians.”

“There are limited published randomized trial data evaluating treatment regimens specifically in the second-line setting for patients with chronic lymphocytic leukemia, contributing to the wide variability in treatment patterns seen in this setting,” said Cyndi Sirard, MD, Medical Director, Genzyme Transplant and Oncology, and an author of the study. “The CAM314 trial advances our understanding of how to use Campath in combination with Fludara and may offer an alternative to existing regimens used in this setting.”

With a median of 17 months of follow up at the time of the second interim analysis, and as assessed by the independent data safety monitoring panel (IRRP), the FluCAM arm demonstrated superior progression free survival in comparison to Fludara alone, with median PFS of 29.6 months on the FluCAM regimen compared to 20.7 months for patients on Fludara, reducing the risk of disease progression or death by 39 percent>

In addition, according to clinical trial investigator assessments, the FluCAM regimen provided significantly higher overall and complete response rates. The overall response rate of patients on FluCAM was 84.8 percent compared to 67.9 percent on Fludara (p<0.001). The complete response rate was 30.4 percent on FluCAM versus 16.4 percent on Fludara>

An additional secondary endpoint, overall survival, did not reach significance at this interim analysis.

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