Arzerra trial for CLL meets endpoint in interim analysis - GSK/Genmab
GlaxoSmithKline and Genmab have announced that an Independent Data Monitoring Committee (IDMC) interim analysis of a Phase III study, PROLONG (OMB 112517), of Arzerra (ofatumumab) in patients with relapsed Chronic Lymphocytic Leukaemia (CLL) who responded to treatment at relapse, reached the predefined significance level for efficacy (p≤0.001). The interim analysis demonstrated that treatment with met the primary endpoint of improving progression free survival (PFS). The study evaluated ofatumumab maintenance therapy versus no further treatment (observation).
The primary endpoint of the study is PFS. Secondary objectives will evaluate clinical benefit, safety, tolerability, the health-related quality of life of subjects treated with ofatumumab versus no further treatment, and pharmacokinetics among relapsed CLL patients receiving maintenance therapy with ofatumumab. The IDMC 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.
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