A phase III trial of Arzerra as a maintenance therapy for chronic lymphocytic leukemia met its primary endpoint of extending progression-free survival at an interim analysis.
The study evaluated Arzerra (ofatumumab) maintenance therapy versus no further treatment and observation in patients with relapsed CLL who responded to treatment at relapse.
The independent data monitoring committee did not identify any new safety signals and will continue to monitor patients for safety until all study patients complete therapy.
Further analysis of the safety and efficacy data is underway and will be shared with regulators and the scientific community in the coming months, according to Arzerra’s sponsors, GlaxoSmithKline plc and Genmab A/S.
Patients in the ofatumumab arm of the study, named PROLONG, received an initial dose of 300 mg of ofatumumab, followed one week later by a second dose of 1,000 mg, then doses of 1,000 mg every eight weeks for up to two years, while patients in the observation treatment arm receive no further treatment.
Arzerra is a monoclonal antibody designed to target the CD20 molecule found on the surface of CLL cells and normal B lymphocytes. It is not approved or licensed anywhere in the world as maintenance treatment for relapsed CLL.
In the U.S., ofatumumab is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate.
