' Adding the investigational monoclonal antibody obinutuzumab (GA101, Genentech) to chlorambucil in elderly patients with chronic lymphocytic leukemia (CLL) more than doubled time to disease progression in a phase 3 trial.
"Effectively, this ends the era of chlorambucil monotherapy," study author Valentin Goede, MD, clinical scientist in the Department of Hematology at the University of Cologne, Germany, told Medscape Medical News.
Dr. Goede presented the first set of results from the CLL11 trial during the Presidential Symposium here at the 18th Congress of the European Hematology Association.'
"This finding suggests an 86% reduction in the risk for a progression, relapse, or death in the obinutuzumab arm," Dr. Goede pointed out.
He noted that these data, particularly the progression-free survival for the obinutuzumab group, might improve with time because the data are still immature.'
Marketing applications have been submitted on the basis of the CLL11 data to regulatory authorities, including the European Medicines Association and the US Food and Drug Administration (FDA). A launch in the United States is expected by the end of this year.
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