Genzyme Announces Results of Phase 3 Trial of Clolar in Adult AML
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct 20, 2010 - 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.
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.
This press release contains forward-looking statements regarding Genzyme's future plans and business strategies, including its expectations about the timing of results from the front-line adult AML clinical trial and anticipated discussions with regulatory authorities about the CLASSIC I study results. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements, including the outcome and timing of the front-line adult AML trial, the timing and outcome of discussions with regulatory agencies regarding Clolar, the actual safety and efficacy of Clolar for the indications in which it is being tested and the risks and uncertainties described in reports filed by Genzyme with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation the information under the heading “Risk Factors” in Genzyme's Quarterly Report on Form 10-Q for the quarter ending June 30, 2010. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and Genzyme undertakes no obligation to update or revise these statements.
Genzyme® and Clolar® are registered trademarks of Genzyme Corporation or its subsidiaries. All rights reserved.
Genzyme's press releases and other company information are available at www.genzyme.com and by calling Genzyme's investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.
Posted: October 2010