Ofatumumab monotherapy in fludarabine-refractory chronic lymphocytic leukemia: final results from a pivotal study
2015
Abstract
While fludarabine-based regimens are a standard for treatment of chronic lymphocytic leukemia (CLL), patients who become refractory to fludarabine have had low response rates with salvage therapy and poor survival outcomes. We reported that ofatumumab, a human monoclonal antibody that binds to a distinct epitope of the CD20 molecule on B cells, was effective as monotherapy for fludarabine-refractory CLL at the interim analysis.
Here we report the final analysis of the study, including a landmark analysis demonstrating clinical benefit in patients who responded and the results of pharmacokinetic analyses and of exploratory analyses to identify factors associated with ofatumumab pharmacokinetics and clinical outcomes.