Celgene says results published in The Lancet Oncology from AZA-001, a randomized Phase III study conducted in patients with higher-risk myelodysplastic syndromes, indicate that Vidaza (azacitidine) demonstrated a significant extension of overall survival compared to conventional care regimens (CCR).
The median overall survival for people with Intermediate-2 and high-risk MDS and acute myeloid leukemia with 20% to 30% bone marrow blasts treated with Vidaza (n=179) was 24.5 months compared to 15 months for those receiving CCR treatment (n=179), an improvement of 9.5 months (p=0.0001), with a 42% reduction in the risk of death. The two-year survival rate was nearly double at 50.8% for patients receiving the drug versus 26.2% for placebo (p=0.0001).
In addition, 45% of patients achieved red-blood cell transfusion independence vs 11% of those receiving CCR treatment (p<0.0001) and 85.3% of red-blood cell transfusion independent Vidaza subjects remained so.
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