Eisai And Janssen Announce The Presentation Of DACOGEN® (decitabine) Data At ASCO From A Phase III Study In Patients With Acute Myeloid Leukemia
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.
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV