Phamion Releases Data From Vidaza Phase III Study
Pharmion announced topline results from a Phase III trial of Vidaza versus conventional care regimens (CCR) in patients with higher-risk myelodysplastic syndromes (MDS), a group of diseases in which the bone marrow does not function normally, resulting in the production of malformed or immature blood cells.
According to Pharmion, the multicenter, randomized, open-label, parallel-group Phase III study of subcutaneous Vidaza (azacitidine for injection) compared a 75-mg/m2 per day dose of the drug for seven consecutive days every 28 days plus best supportive care with CCR plus best supportive care.
The company said CCR consisted of one of three physician-selected regimens: best supportive care alone, low-dose cytarabine plus best supportive care or standard chemotherapy plus best supportive care. EPO and prophylactic G-CSF use was not permitted, the company added.
According to the company, the study evaluated 358 higher-risk MDS patients at sites in the U.S., Europe and Australia.
In the primary endpoint analysis, Vidaza was associated with a median survival of 24.4 months versus 15 months for those receiving CCR treatment, the company said.
The survival benefits of Vidaza were consistent regardless of the CCR treatment option utilized in the control arm, the company added.