Ofatumumab plus Chlorambucil Improves Progression-free Survival in Patients with Previously Untreated CLL
In a phase III study, patients with previously untreated chronic lymphocytic leukemia (CLL) achieved an improvement in progression-free survival when treated with ofatumumab (Arzerra) in combination with chlorambucil vs chlorambucil alone.
The study evaluated safety and efficacy of ofatumumab plus chlorambucil in 447 patients with previously untreated CLL who were considered inappropriate for fludarabine-based therapy. Patients were randomly assigned (1:1) to treatment with up to 12 cycles of ofatumumab in combination with chlorambucil or up to 12 cycles of chlorambucil alone. The trial’s primary endpoint was progression-free survival.
Results
A 9.3-month improvement in progression-free survival was seen in patients treated with ofatumumab and chlorambucil (22.4 months) compared to patients treated with chlorambucil alone (13.1 months) (HR = 0.57; P < .001).
There were no unexpected safety findings. The most common serious adverse events were neutropenia (5%), anemia (4%), pneumonia (4%), and pyrexia (2%). Infusion reactions were mild to moderate in severity with 3% of infusion reactions reported as serious.
According to Genmab, codeveloper of ofatumumab, the study results, including secondary endpoints, will be submitted for presentation at the International Workshop on CLL in Cologne, Germany, in September.
Ofatumumab is being developed by GlaxoSmithKline and Genmab.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
