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news.MGI Pharma has revealed positive results from a phase III trial evaluating its investigational drug Dacogen injection in the treatment of patients with myelodysplastic syndromes, a group of bone marrow disorders which can lead to leukemia.
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The trial compared Dacogen with supportive care for the treatment of myelodysplastic syndromes (MDS). The drug is currently under review by the FDA for use in this indication.
Co-primary endpoints of the study were overall response rate (complete responses plus partial responses) and time to acute myeloid leukemia (AML) transformation or death.
Secondary endpoints included hematologic improvement, duration of response, cytogenetic response rate, transfusion requirements, quality of life, survival, and safety.
The overall response rate was 17%, including a complete response rate of 9% and a partial response rate of 8%. The overall improvement rate for patients who received Dacogen was 30% compared to 7% for those who received supportive care alone.
All patients who responded to Dacogen treatment became or remained transfusion independent, and cytogenetic complete responses were observed in 35% of patients treated with the drug. The most common adverse events related to Dacogen were neutropenia, thrombocytopenia, and anemia.
MDS are a group of diseases of the bone marrow characterized by the production of poorly functioning and immature blood cells. People with MDS may experience a variety of symptoms and complications, including anemia, bleeding, infection, fatigue and weakness. Those patients with high-risk MDS may experience bone marrow failure, which may lead to death from bleeding and infection. Over time, MDS can progress to acute leukemia.