Genzyme’s Campath Meets Primary Endpoint in Phase 3 Combination Therapy Trial for Chronic Lymphocytic Leukemia

Significant Improvement in Progression Free Survival Seen in Relapsed or Refractory Patients

28-Sep-2009 - USA

Genzyme Corporation announced that its randomized 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 percent overall improvement in progression free survival in the FluCAM arm in comparison to the Fludara arm.

Study results from this interim analysis are expected to be submitted to the American Society of Hematology meeting held in December.

“The standard of care for patients with chronic lymphocytic leukemia is evolving, as active single agents are studied in combination,” said Cyndi Sirard, MD, Medical Director, Genzyme Transplant and Oncology. “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.”

Based on the study’s positive findings, Genzyme intends to seek regulatory approval in the United States, European Union, and other countries to further broaden the Campath label to include the use of this combination regimen. If the expanded label is granted, Campath, marketed as MabCampath® in Europe, would be the first humanized monoclonal antibody approved as both a single agent and in combination therapy for the treatment of CLL.

https://www.bionity.com/en/news/106899/genzymes-campath-meets-primary-endpoint-in-phase-3-combination-therapy-trial-for-chronic-lymphocytic-leukemia.html