Genzyme reports results of Clolar combination Phase 3 trial in adult AML

Genzyme Corporation (Nasdaq: GENZ) announced results today from its CLASSIC I phase 3 trial comparing Clolar® (clofarabine) in combination with the chemotherapy agent cytarabine (ara-c) to cytarabine plus placebo in relapsed-refractory adult acute myeloid leukemia (AML). Although the study did not show a difference between the arms in the primary endpoint of overall survival, the Clolar combination demonstrated statistical significance across all four pre-specified secondary efficacy endpoints: overall remission rate; complete remission rate; event-free survival; and four-month event free survival.

"Of importance, the Clolar combination doubled the overall remission rate to 47 percent," said Hagop Kantarjian, M.D., MD Anderson Cancer Center. "Also, we see a 37 percent improvement in event-free survival, a particularly important measure of clinical benefit."

Preliminary review of adverse events revealed no new safety signals.

"We remain committed to the development of Clolar in adult acute myeloid leukemia," said Mark Enyedy, Genzyme President of Transplant, Oncology, and Multiple Sclerosis. "We are collaborating with the United Kingdom's National Cancer Research Institute on a large randomized clinical trial in front-line adult AML." Data from this study is anticipated in 2011.

The CLASSIC I study was a randomized, double-blind, placebo-controlled clinical trial that compared Clolar in combination with cytarabine to cytarabine plus placebo in patients 55 years and older with AML who relapsed or were refractory after receiving up to two prior induction regimens. The combination of Clolar with cytarabine was developed by Stefan Faderl, M.D. and colleagues at the MD Anderson Cancer Center. Dr. Faderl served as the principal investigator of CLASSIC I, which enrolled 326 patients in North America and Europe. The event driven trial was powered to detect at least a 50 percent improvement in overall median survival in the Clolar plus cytarabine combination arm.

The CLASSIC I study results will be submitted to an upcoming medical meeting and discussed with regulatory authorities.