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Sep 24, 2009

Phase III Success Could Mean Label Expansion for Genzyme’s CLL Drug

  • Genzyme is reporting that Campath® plus Fludara prolongs progression-free survival (PFS) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Having met its primary endpoint in a Phase III study as assessed during an interim analysis, the trial’s independent data safety monitoring board recommended early closure of the study.

    Campath is approved for B-cell CLL and Fludara for CLL in patients who have been treated with at least one other medication. Genzyme intends to seek regulatory approval in the U.S., EU, and other countries to broaden the Campath label to include the use of this combination regimen.

    The CAM314 multicenter, international, open-label, randomized Phase III study included 335 patients with progressive stage I–IV CLL. It compared Campath in combination with Fludara (FluCAM) to Fludara alone. Genzyme will continue to assess overall survival, which is a secondary endpoint along with overall response, complete response, safety, and three-year survival.

    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. Patients in the trial received one prior therapy and excluded patients who were refractory to Fludara or Campath. FluCAM patients received Campath in escalating doses of 3, 10, and 30 mg IV for up to 14 days. The patients then received Fludara at 30 mg/m2 IV followed by Campath 30 mg IV every 28 days for up to six cycles. Patients in the Fludara arm received Fludara at 25 mg/m2 IV daily for five consecutive days every 28 days for up to six cycles.

    “The standard of care for patients with chronic lymphocytic leukemia is evolving, as active single agents are studied in combination,” notes Cyndi Sirard, M.D., 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.”

    If the expanded label is granted, Campath, marketed as MabCampath® in Europe, would be the first humanized mAb sanctioned as a single agent and as a combination therapy for the treatment of CLL, according to Genzyme.

     



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