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Eisai Inc. and Janssen, a Johnson & Johnson Company, both announced the presentation of data from the DACO-016 trial of DACOGEN® (decitabine) at the 2011 Annual Meeting of the American Society of Clinical Oncology (ASCO). The data demonstrate a clinical improvement in overall survival in older patients with newly diagnosed de novo or secondary acute myeloid leukemia (AML) as defined by the World Health Organization (WHO). AML is a life-threatening cancer of the blood for which there are limited treatment options.
DACO-016 compared decitabine to a patient’s treatment choice with physician advice of either supportive care or low-dose cytarabine in the treatment of older patients with AML, the primary endpoint of the study was overall survival. The analysis at the protocol-specified cutoff with 396 (81.6%) deaths demonstrated an increase of greater than 50% in median overall survival in patients taking decitabine (7.7 months for decitabine patients compared to 5.0 months for patients in the comparator arm), HR=0.85, 95% CI: 0.69, 1.04, p=0.108. An updated unplanned analysis of more mature survival data with additional one year of patient follow up and 446 (92%) deaths confirmed this trend for improved overall survival (HR=0.82; 95% CI: 0.68, 0.99; nominal p=0.037).
Dr. Xavier G. Thomas of the Hospital Edouard Herriot in Lyon, France, one of the lead DACO-016 investigators, comments: “Compared with the accepted standard therapies used in this study to treat older patients with AML, DACOGEN showed a clinically relevant overall survival advantage without major differences in safety.”
DACO-016 was conducted in 485 patients, making it the largest AML trial to date in older patients. It was a Phase 3, randomized, open-label trial, in newly diagnosed patients ≥65 years of age with de novo or secondary AML and poor- or intermediate-risk cytogenetics. Patients were enrolled globally at 65 clinical sites. Of the 485 patients, 242 were randomized to decitabine and 243 to patient’s treatment choice of supportive care or low-dose cytarabine (majority of patients, 88% received low-dose cytarabine). Patients treated with decitabine received a 1-hour infusion, once daily for 5 consecutive days every 4 weeks. Patients treated with cytarabine received 20 mg/m2 subcutaneously once daily 10 consecutive days every 4 weeks. The median duration of treatment for patients on decitabine arm was 4.4 months, compared with 2.4 months in the cytarabine group.