Survival analysis pooled results from France, Germany, Italy, Spain, UK, Sweden, Greece and the Netherlands
Celgene International Sàrl (Nasdaq:CELG) today announced that data showed VIDAZA (azacitidine) provides a significant overall survival benefit for patients with higher-risk myelodysplastic syndromes (MDS) regardless of whether patients were treated with low-dose Ara-C or best supportive care in the control arm. In aggregate, the survival benefit for VIDAZA across all countries was 24.4 months versus 15.3 months (hazard ratio 0.36) (95% Cl: 0.20-0.65) [p=0.0006]) compared to the other treatment arms. The data were presented at the 13th Congress of the European Hematology Association (EHA) in Copenhagen, Denmark.
VIDAZA was compared with low-dose Ara-C in the UK and France, and compared with best supportive care in Germany, Italy, Sweden, Greece, Spain and the Netherlands. In both groups, VIDAZA consistently showed an overall survival benefit. VIDAZA is a novel epigenetic therapy that may restore normal expression to genes critical for cell differentiation and proliferation.
“These data reinforce VIDAZA’s role and the importance of this epigenetic drug in the treatment paradigm for higher-risk MDS patients,” said Professor Valeria Santini, hematologist and lead investigator of the trial, University of Florence. “These results continue to show that VIDAZA can provide a significant overall survival benefit regardless of which regimen is used for comparison.”
The results from this trial are consistent with the data from the large, international, multi-center Phase III trial AZA-001, recently presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, which demonstrated that VIDAZA was the first drug to significantly prolong overall survival in higher-risk MDS patients.
The most commonly occurring major adverse events for patients receiving VIDAZA are thrombocytopenia (69.7%), neutropenia (65.7%) and anemia (51.4%).
About VIDAZA
In May 2004, VIDAZA became the first drug approved in the United States by the FDA for the treatment of patients with Myelodysplastic Syndromes (MDS). VIDAZA was approved for IV administration in January 2007. The FDA approved VIDAZA, the first in a new class of drugs called demethylation agents, for treatment of all five MDS subtypes, which include both low-risk and high-risk patients.
