Genzyme has presented data from its CAM314 randomised 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).
The study demonstrated that the FluCAM regimen reduced the risk of disease progression or death compared to single-agent Fludara. The advanced stage, second-line CLL patients receiving FluCAM has doubled the amount of time without disease progression in comparison to patients receiving Fludara alone.
The company said that after a planned second interim analysis, the CAM314 trial’s data safety monitoring panel recommended early closure of the study as it had achieved the study’s primary endpoint, the pre-specified clinical and statistical significance in progression free survival (PFS).
While patients in the study continue to be followed, the 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 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.
Cyndi Sirard, medical director of Genzyme Transplant and Oncology, and an author of the study, said: “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.”