Data presented demonstrate prolonged overall survival for patients with acute myeloid leukemia

December 10, 2008

The Myelodysplastic Syndromes (MDS) Foundation announced today that data presented at this year's American Society of Hematology (ASH) Meeting in San Francisco demonstrate that patients with acute myeloid leukemia (AML) who were treated with VIDAZA (azacitidine) had significantly increased overall survival compared to those treated with conventional care regimens (CCR).

AML is a cancer of myeloid blood cells where abnormal cells accumulate in the bone marrow and interfere with normal blood cell production. Patients with AML typically have a poor prognosis and do not respond well to conventional chemotherapy. Roughly 30 percent of patients diagnosed with MDS will progress to AML.

Dr. Pierre Fenaux, of the University of Paris, presented the updated results from an international phase III trial (AZA-001) which was the first study to show an increased overall survival for higher-risk MDS patients. One-third of patients enrolled in the trial met the World Health Organization (WHO) criteria for AML. This analysis showed that 50 percent of the AML patients who were treated with VIDAZA survived at least two years, compared to only 16 percent of patients treated with CCR.

"The data presented at this year's ASH Meeting are encouraging for both physicians and patients and demonstrate the major advancements that have been made in treating hematologic conditions, like MDS and AML, over the past several years," said Kathy Heptinstall, Operating Director of the Myelodysplastic Syndromes Foundation, "We are hopeful about the potential of novel therapies, like VIDAZA, which are helping patients to live longer with a better quality of life."

The data presented today are a follow-up to results from the AZA-001 trial presented at the American Society of Clinical Oncology Meeting in June, which showed that patients with high-risk MDS who received VIDAZA had higher one-year survival rates in all response categories, including partial remission, stable disease and hematologic improvement, compared to those who received CCR without necessarily achieving complete remission.

Source: MDS Foundation

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