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news.Pharmion has announced complete results from a Phase III multi-center, international, randomized study of Vidaza in the treatment of patients with higher-risk myelodysplastic syndromes demonstrating that the drug provides a significant survival benefit compared to conventional care regimens in higher-risk myelodysplastic syndromes patients.
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The median overall survival advantage for Vidaza-treated patients compared to conventional care regimens (CCR) treated patients in this clinical trial in myelodysplastic syndromes (MDS) was 9.4 months (24.4 months vs. 15 months). The hazard ratio describing this treatment effect was 0.58 (95% confidence interval of 0.43 to 0.77).
With a median follow-up of 21.1 months, Vidaza demonstrated a statistically significant overall survival advantage over CCR (24.4 months vs. 15 months). At two years, Vidaza demonstrated a two-fold advantage in overall survival over CCR (51% vs. 26%).
Patrick Mahaffy, president and CEO of Pharmion, said: “As the only hypomethylating agent, and, in fact, the only drug to have shown an improvement in overall survival, we believe Vidaza now stands alone as the standard of care for higher-risk MDS patients. In addition to the unprecedented improvement in overall survival, 45% of patients on Vidaza achieved transfusion independence compared to 11% on CCR, and for patients on Vidaza, the median time to transformation to acute myeloid leukemia during the treatment period was 26 months, compared to 12 months for patients on CCR therapy. These data provide further evidence of the substantial benefit that Vidaza provides to higher-risk MDS patients in prolonging their lives.”