Pomalidomide: Phase I/II data

Data from the Phase II portion of the open-label, dose-escalation, North American Phase I/II CC-4047-MM-002 trial in 191 evaluable patients showed that oral pomalidomide plus low-dose dexamethasone led to a median PFS, the primary endpoint, of 4.7 months vs. 2.7 months for pomalidomide alone. Additionally, 34% of patients receiving pomalidomide plus dexamethasone achieved a partial response or better vs. 13% for pomalidomide alone, while an objective response, defined as a minor response or better, was achieved in 45% and 29% of patients, respectively. Median OS and duration of response were 16.9 and 7.9 months, respectively, for the combination arm vs. 14 and 8.5 months for pomalidomide alone. The most common grade 3/4 adverse events were neutropenia, anemia, pneumonia, thrombocytopenia and fatigue. The trial enrolled patients with relapsed and refractory MM who had received at least 2 prior therapies, including Revlimid lenalidomide and Velcade bortezomib, to receive once-daily 4 mg pomalidomide on days 1-21 every 28 days with or without weekly 40 mg dexamethasone. Data were presented at the American Society of Hematology meeting in San Diego. ...