Document Detail


Phase I study of obinutuzumab (GA101) in Japanese patients with relapsed or refractory B-cell non-Hodgkin lymphoma.
MedLine Citation:
PMID:  23046388     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
As CD20 has become an established target for treating B-cell malignancies, there is interest in developing anti-CD20 antibodies with different functional activity from rituximab that might translate into improved efficacy. Obinutuzumab (GA101) is a glycoengineered, humanized type II anti-CD20 monoclonal antibody that has demonstrated superior activity to type I antibodies in preclinical studies and is currently being investigated in phase III trials. In this phase I dose-escalating study in Japanese patients with relapsed/refractory B-cell non-Hodgkin lymphoma, the primary endpoint was to characterize the safety of GA101; secondary endpoints were efficacy, pharmacokinetics and pharmacodynamics. Patients received up to nine doses of GA101 with up to 52 weeks' follow up. Most adverse events were grade 1 or 2 infusion-related reactions, and 10 grade 3/4 adverse events occurred. No dose-limiting toxicities were observed and the maximum tolerated dose was not identified. Out of 12 patients, 7 responded (end-of-treatment response rate 58%), with 2 complete responses and 5 partial responses. Responses were observed from low to high doses, and no dose-efficacy relationship was observed. B-cell depletion occurred in all patients after the first infusion and was maintained for the duration of treatment. Serum levels of GA101 increased in a dose-dependent fashion, although there was inter-patient variability. This phase I study demonstrated that GA101 has an acceptable safety profile and offers encouraging activity to Japanese patients with relapsed/refractory B-cell non-Hodgkin lymphoma.
Authors:
Michinori Ogura; Kensei Tobinai; Kiyohiko Hatake; Toshiki Uchida; Tatsuya Suzuki; Yukio Kobayashi; Masakazu Mori; Yasuhito Terui; Masahiro Yokoyama; Tomomitsu Hotta
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Publication Detail:
Type:  Clinical Trial, Phase I; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2012-11-12
Journal Detail:
Title:  Cancer science     Volume:  104     ISSN:  1349-7006     ISO Abbreviation:  Cancer Sci.     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-01-10     Completed Date:  2013-03-05     Revised Date:  2013-11-05    
Medline Journal Info:
Nlm Unique ID:  101168776     Medline TA:  Cancer Sci     Country:  England    
Other Details:
Languages:  eng     Pagination:  105-10     Citation Subset:  IM    
Copyright Information:
© 2012 Japanese Cancer Association.
Affiliation:
Department of Hematology and Oncology, Nagoya Daini Red Cross Hospital, Nagoya, Japan. mi-ogura@naa.att.ne.jp
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Antibodies, Monoclonal, Humanized / adverse effects,  pharmacokinetics,  therapeutic use*
Antigens, CD20 / immunology*
Antineoplastic Agents / adverse effects,  pharmacokinetics,  therapeutic use*
Female
Humans
Japan
Lymphoma, B-Cell / drug therapy*
Male
Middle Aged
Recurrence
Young Adult
Chemical
Reg. No./Substance:
0/Antibodies, Monoclonal, Humanized; 0/Antigens, CD20; 0/Antineoplastic Agents; O43472U9X8/obinutuzumab

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