CHICAGO and BEERSE, Belgium, June 6, 2011 /PRNewswire/ --
- Data From DACO-016 Trial at 2011 American Society of Clinical
Oncology Annual Meeting
- NB: Data in this release corresponds to ASCO abstract 6504
Data from the DACO-016 trial of DACOGEN(R) (decitabine) presented today at the 2011 Annual Meeting of the American Society of Clinical Oncology (ASCO), demonstrate a clinically significant improvement in overall survival in older patients with newly diagnosed de novo or secondary acute myeloid leukemia (AML) as defined by the World Health Organisation (WHO). AML is a life-threatening disease that affects primarily older adults; very limited treatment options exist.
DACO-016 compared decitabine to a patient's choice with physician advice of either supportive care or low-dose cytarabine in the treatment of older patients with AML. The analysis of the protocol-specified results demonstrated a statistically non-significant increase of greater than 50 percent in median overall survival in patients taking decitabine (7.7 months for decitabine patients, (HR=0.85, 95 percent CI: 0.69, 1.04, p=0.108) compared to 5.0 months for patients in the comparator arm). An updated analysis of mature survival data confirmed this strong trend for improved overall survival and provided clinically significant evidence of decitabine efficacy (HR=0.82; 95 percent 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, randomised, 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 randomised to decitabine and 243 to patient's treatment choice of supportive care or low-dose cytarabine (majority of patients, 88%). 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.
Adverse events (AEs) were consistent with the known decitabine safety profile and without major differences between the treatment arms. The most frequently reported Grade 3 or 4 hematologic AEs were thrombocytopenia, anemia, neutropenia, and febrile neutropenia.