Dacogen Phase III study results on acute myeloid leukemia presented at ASCO 2011

Results from the DACO-016 trial of Dacogen® (decitabine) in acute myeloid leukemia (AML) were presented today at the 2011 Annual Meeting of the American Society of Clinical Oncology (ASCO). AML is a life-threatening cancer of the blood for which there are limited treatment options.

The 485-patient, open-label, multi-center study compared Dacogen versus treatment choice (TC) of either supportive care or low-dose cytarabine in older patients with newly diagnosed or secondary AML. The primary endpoint of the study was overall survival.

The results of the analysis showed that at the protocol-defined clinical cutoff, with 396 (81.6%) deaths, Dacogen demonstrated an overall survival advantage but did not demonstrate statistically significant superiority over the control arm. Patients treated with Dacogen had a median survival of 7.7 months (HR 0.85: 95% CI: 6.2, 9.2).

The updated unplanned analysis, conducted with an additional year of patient follow-up, demonstrated the same median survival benefit for patients treated with Dacogen. With 446 (92%) deaths, it showed that patients in the Dacogen arm had a median survival of 7.7 months vs. 5 months in the TC arm (HR 0.82: 95% CI: 0.68, 0.99: nominal).

Adverse events were consistent with the known Dacogen safety profile and without major differences between the treatment arms. The most commonly reported Grade 3 or 4 adverse events were thrombocytopenia (reported in 40%, 32%, 35% and 14% of subjects in the Dacogen, TC, cytarabine and supportive care groups, respectively), anemia (34%, 25%, 27% and 14%, respectively), neutropenia (32%, 42%, 20% and 3%, respectively) and febrile neutropenia (32%, 22%, 25% and 0%, respectively).

"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," said Dr. Xavier Thomas of the Edouard Herriot Hospital in Lyon, France and one of the lead investigators of the study.