Arzerra ofatumumab: Interim Phase II data

Interim data from an ongoing, open-label Phase II trial in 14 evaluable patients showed that ofatumumab produced 3 partial responses and 3 minor responses at 8 weeks to 5 months after the start of treatment. One patient developed grade 3 neutropenia and 2 patients experienced a rapid rise in IgM, which can lead to complications of hyperviscosity. Patients received a single 300 mg IV infusion of ofatumumab during week 1, followed by weekly 1,000 mg infusions during weeks 2-4. Based on the safety profile and the approved dose of ofatumumab for refractory chronic lymphocytic leukemia (CLL), the trial was amended to increase the dose of ofatumumab to 2,000 mg and to allow a second cycle of therapy for patients who do not achieve a partial response after the first cycle. Data will be presented at the American Society of Hematology meeting in Orlando in December. ...