New Phase III data for Vidaza in AML - Celgene

Celgene has announced results from AML-001, a Phase III study of Vidaza (azacitidine for injection) compared to conventional care regimens (CCR) in elderly subjects with newly-diagnosed Acute Myeloid Leukemia (AML - >30% blasts). Median overall survival (OS), the primary endpoint of the study, was 10.4 months for patients receiving azacitidine compared to 6.5 months for patients receiving CCR, which did not achieve statistical significance.

Additionally, a pre-specified sensitivity analysis for OS that censored patients at the start of subsequent AML therapy was conducted. Results of this analysis showed a longer median overall survival for patients receiving azacitidine (median 12.1 months) compared to patients receiving CCR (median 6.9 months). One-year survival was 47% for patients receiving azacitidine compared to 34% for patients receiving CCR. Data were presented in a late-breaking abstract oral session at the 19th European Hematology Association annual congress.