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news.In phase 3 combination therapy trial for chronic lymphocytic leukemia
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Genzyme has announced that its randomised phase 3 clinical trial investigating Campath (alemtuzumab) in combination with Fludara (fludarabine phosphate) in relapsed or refractory chronic lymphocytic leukemia (CLL) patients met its primary endpoint by demonstrating a significant improvement in progression free survival (PFS).
The trial’s independent data safety monitoring board, in a pre-planned interim analysis, determined that the study achieved its primary endpoint (p<0.0173) and recommended early closure of the trial. Patients in the international, multi-center study treated with Campath in combination with Fludara (FluCAM) experienced a significant increase in the amount of time they lived without the disease progressing compared to patients treated with Fludara alone. The trial was designed to detect at least a 50% overall improvement in progression free survival in the FluCAM arm in comparison to the Fludara arm.
Cyndi Sirard, medical director of transplant and oncology at Genzyme, said: “The standard of care for patients with chronic lymphocytic leukemia is evolving, as active single agents are studied in combination. Campath has proven to be a highly active single agent therapy across the spectrum of this disease, and Fludara is considered a backbone of CLL therapy. These trial results are anticipated to provide clinically meaningful data supporting Campath use in combination with Fludara in patients with relapsed or refractory CLL.”
Doug Burcz, vice president and general manager of Genzyme, said: “Pending approval, the FluCAM dosing regimen used in the phase 3 trial will extend the use of Campath by giving physicians an important alternative treatment regimen for their patients with progressive disease.”
In the CAM314 trial, patients in the FluCAM arm had lower total exposure to Campath and Fludara when dosed in combination, as compared to the labeled, single-agent dosing regimen of each drug for the treatment of CLL.
Based on the study’s positive findings, Genzyme intends to seek regulatory approval in the US, EU, and other countries to further broaden the Campath label to include the use of this combination regimen.