Switzerland-based Celgene (CELG) subsidiary Celgene Interantional Sarl announces the results from a Phase 3 clinical trial evaluating the safety and efficacy of Vidaza (azacitidine for injection) compared to conventional care regimens (CCR) in elderly patients with newly-diagnosed acute myeloid leukemia (AML).
The primary endpoint was median overall survival (OS). The OS for the azacitidine group (n=241) was 10.4 months (8.0 - 12.7 months; 95% CI) compared to 6.5 months (5.0 - 8.6 months; 95% CI) in the CCR group (n=247). The results failed to achieve statistical significance.
One-year survival was 47% in the azacitidine cohort compared to 34% of patients receiving CCR.
The clinical trial was conducted to support a possible label expansion for Vidaza. It is currently indicated for treatment of patients with certain types of refractory anemia.