BioCentury
ARTICLE | Clinical News

Vidaza azacitidine: Phase II data

December 17, 2012 8:00 AM UTC

Top-line data from an investigator-initiated Phase II trial in 42 patients aged 60 years and older with untreated AML showed that once-daily 75 mg/m 2 Vidaza on days 1-7 followed by once-daily 50 mg Revlimid lenalidomide on days 8-28 of a 42-day cycle led to an ORR of 41%, with 28% of patients achieving a complete response (CR) or CR with incomplete blood count recovery (CRi). Median time to CR was 12 weeks and median time to CRi was 6 weeks. Additionally, median duration of response was 28 weeks. Median OS was 20 weeks for all patients and 69 weeks for patients who responded to therapy compared to 15 weeks for non-responders (p<0.01). Data were presented at the American Society of Hematology meeting in Atlanta. A 3-arm Phase II in elderly AML patients is evaluating Vidaza monotherapy, Revlimid monotherapy and Vidaza followed by Revlimid. ...