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news.Celgene International Sarl has announced encouraging results from a sub-analysis of a previously reported large, randomized Phase III study, which showed that treatment with Vidaza prolonged overall survival for patients with high-risk myelodysplastic syndromes when compared to conventional care regimens.
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This analysis evaluated a sub-group of patients (n=94) who were pre-selected to receive low dose Ara-C, a chemotherapy used in the treatment of myelodysplastic syndromes and acute myeloid leukemia.
The results confirm that the significant survival benefit originally reported with Vidaza in the overall population was also seen when Vidaza was directly compared to the active comparator arm of low dose Ara-C.
In the sub-analysis, the median overall survival for patients treated with Vidaza was significantly longer (24.4 months compared to 15.3 months (hazard ratio 0.36) compared to patients treated with low-dose Ara-C, reducing the risk of death by 64%. This improved survival with Vidaza was supported by significant improvements in hematologic response, and improvement in transfusion independence.