Pharmion's Vidaza achieves survival benefit in MDS

USA-based drugmaker Pharmion says that Phase III data from a trial of Vidaza (azacitidine for injection) in patients suffering higher-risk myelodysplastic syndrome show that the drug provides a significant survival benefit over conventional care regimens. Specifically, treatment conferred a 9.4 month improvement in overall survival (24.4 months versus 15 months).

The study, which was a randomized, open-label assessment, was designed to demonstrate the superiority of azacitidine versus CCR in 358 higher-risk MDS patients at sites in the USA, Europe and Australia. Participants were assigned to receive a subcutaneous administration of azacitidine (75mg/m2/day) for seven consecutive days of a 28-day cycle, or CCR. Those in the CCR group were entitled to either best supportive care, low-dose cytarabine or standard chemotherapy.

Speaking at this year's meeting of the American Society of Hematology in Atlanta, Pharmion's chief executive, Patrick Mahaffy, said: "in addition to the unprecedented improvement in overall survival, 45% of patients on azacitidine achieved transfusion independence compared to 11% on CCR." He added that the median time to transformation to acute myeloid leukemia was 26 months, compared with 12 months in the CCR group.