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news.Eisai Corporation of North America, a wholly-owned subsidiary of Eisai Co and a healthcare company, has announced that it plans to initiate the first clinical trial evaluating the activity of Dacogen compared to Vidaza in adult patients with intermediate-1, intermediate-2 or high-risk myelodysplastic syndromes.
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This randomized, multi-center, open-label study will be conducted among 228 adult patients with intermediate-1, intermediate-2 and high-risk myelodysplastic syndromes (MDS). Patients will be randomized on a 1:1 ratio to either Dacogen or Vidaza. Each treatment arm will be stratified by IPSS risk group and type of MDS.
The study’s primary objective is to compare the complete response rates, including bone marrow response rates, for Dacogen versus Vidaza. The head-to-head trial will be conducted in the US and will directly compare Dacogen to Vidaza with a primary endpoint of complete response rate.
Hagop Kantarjian, chairman of the leukemia department and professor of medicine at University of Texas MD Anderson Cancer Center, said: “Previous to the introduction of the hypomethylating agents, supportive care was the only treatment option for patients living with MDS. This study, for the first time, will provide physicians with important information to understand how these two agents compare when treating patients with MDS, who currently have a generally poor prognosis, with life expectancies shorter than those with lung cancer.”