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Novel monoclonal antibody targets CD20 in relapsed NHL
53rd ASH Annual Meeting
SAN DIEGO — The novel anti-CD20 monoclonal antibody obinutuzumab was linked to better response rates than rituximab in a cohort of patients with relapsed non-Hodgkin’s lymphoma, according to results presented here.
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’s Centre for Lymphoid Cancer in Vancouver, Canada, said obinutuzumab — which is also known as GA101 — has shown better ability to cause cell death than its counterparts in preclinical testing.
“There was a real motivation to develop a new anti-CD20 antibody [that] could improve clinical outcomes,” Sehn said during a press conference. “We are now moving into patient testing to see if that translates into benefit.”
In the current study, 74 patients were assigned obinutuzumab and 75 patients were assigned to rituximab (Rituxan, Genentech/Biogen Idec Pharmaceuticals).
“This is the first head-to-head study of a novel anti-CD20 antibody vs. rituximab,” Sehn said.
The primary outcome measures included overall response rate (ORR), PFS and OS. Safety profiles also were measured for both treatments.
Participants received four weekly injections of either the study drug or rituximab. Responses were assessed between 28 and 42 days after the last dose.
“Patients with stable disease or who responded to the treatment moved on to a maintenance phase for 2 years,” Sehn said.
A 44.6% ORR was observed for obinutuzumab vs. 33.3% among patients assigned to rituximab. The complete remission rate, or unconfirmed complete remission rate, was 12.2% in the obinutuzumab arm and 5.3% in the rituximab arm.
“Tolerability profiles were similar in both arms,” Sehn said. “There was a slightly higher rate of infusion-related reactions with obinutuzumab, and we also saw some cough in this arm, but neither were serious.”
Mild infusion reactions were observed in the obinutuzumab arm, but none resulted in discontinuation of treatment. Five obinutuzumab patients and nine rituximab patients experienced severe adverse events during the 4-week induction period, and more patients receiving rituximab discontinued therapy during induction.
The median follow-up duration was 15 months, according to Sehn.
“There is a trend toward improved response rates compared with rituximab,” Sehn said. “Based on this data, studies to truly test its efficacy are warranted and are now under way.”– by Rob Volansky
Disclosure: Dr. Sehn reports receiving consultancy, honoraria and research funding from Roche/Genentech.
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This is a newly engineered antibody, specifically designed to improve efficacy. Dr. Sehn’s study shows that new technologies are providing us with new tools that we did not have before. We are seeing that it is possible to engineer a highly effective antibody rather than find one.
Jane N. Winter, MD
Professor of
Medicine-Hematology/Oncology
Northwestern University Feinberg School of
Medicine
Disclosure: Dr. Winter reports no relevant financial disclosures.
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