After a complete assessment by both investigators and an independent radiology review, trial data revealed that treatment with GA101 resulted in higher response rates in patients compared to treatment with rituximab. The ORR for GA101 was 43.2 percent versus 38.7 percent for rituximab, and the complete remission (or unconfirmed complete remission) rate in the GA101 arm was 10.8 percent compared to 5.3 percent for rituximab.
Overall, GA101 was well tolerated by most study participants. Although patients on GA101 treatment had a higher rate of infusion reactions, which are a common complication of treatment with monoclonal antibodies, they were generally considered mild and did not result in significant differences in treatment discontinuation. A greater number of patients in the rituximab arm experienced severe adverse events during the four-week induction period (nine patients vs. five GA101 patients). Severe adverse events in GA101 patients included infusion reactions, neutropenia with fever, pleural effusion (a build-up of fluid in the lung tissue), and kidney stones. Finally, more rituximab-treated patients than GA101-treated patients discontinued therapy during the induction period.
"This is the first head-to-head trial of a novel anti-CD20 monoclonal antibody, GA101, against rituximab and we are encouraged to see a trend toward higher response rates without appreciable differences in safety," said lead author Laurie H. Sehn, MD, MPH, Clinical Associate Professor in the Division of Medical Oncology at the University of British Columbia and the British Columbia Cancer Agency, Center for Lymphoid Cancer in Vancouver, Canada. "Given the promising efficacy of this drug, definitive Phase III studies evaluating its benefit are warranted and are currently underway."
Dr. Sehn will present this study in an oral presentation on Monday, December 12, at 8:00 a.m. PST at the San Diego Conventino Center in Ballro
|SOURCE American Society of Hematology|
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