Genzyme Announces Results of Phase 3 Trial of Clolar in Adult AML

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

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.

About Genzyme

One of the world’s leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with approximately 10,000 employees in locations spanning the globe and 2009 revenues of $4.5 billion. In 2010, Genzyme was named to the Fortune 500.

With many established products and services helping patients in 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company’s products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and immune disease. Genzyme’s commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.

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