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J Clin Oncol. 2015 Oct 20;33(30):3467-74. doi: 10.1200/JCO.2014.59.2139. Epub 2015 Aug 17.

Randomized Phase II Trial Comparing Obinutuzumab (GA101) With Rituximab in Patients With Relapsed CD20+ Indolent B-Cell Non-Hodgkin Lymphoma: Final Analysis of the GAUSS Study.

Author information

1
Laurie H. Sehn, Centre for Lymphoid Cancer, British Columbia Cancer Agency and the University of British Columbia, Vancouver, British Columbia; Tara Baetz, Queen's University, Kingston General Hospital, Kingston; Rena Buckstein, Sunnybrook Health Sciences Center; Michael Crump, Princess Margaret Hospital, University of Toronto, Toronto, Ontario, Canada; Andre Goy and Luis E. Fayad, John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ; Fritz C. Offner, Institute of Hematology and Medical Oncology, University of Bologna; Pier Luigi Zinzani, Institute of Hematology "Seràgnoli" University of Bologna, Bologna; Giovanni Martinelli, European Institute of Oncology, Milano; Gianluca Gaidano, Amedeo Avogadro University of Eastern Piedmont, Novara, Italy; M. Dolores Caballero, University Hospital of Salamanca, Salamanca, Spain; Ole Gadeberg, Vejle Hospital, Vejle, Denmark; Andrew D. Zelenetz, Memorial Sloan Kettering Cancer Center, New York; Jonathan Friedberg, James P. Wilmot Cancer Center, University of Rochester, Rochester, NY; Branimir Jadkisic, Clinical Hospital Merkur, University of Zagreb, Zagreb, Croatia; Swaminathan Padmanabhan Iyer, Houston Methodist Cancer Center, Weill Cornell Medical College, Houston, TX; Deniz Sahin and Günter Fingerle-Rowson, Roche, Basel, Switzerland; Akiko Chai, Genentech BioOncology, South San Francisco, CA; Oliver Press, Fred Hutchinson Cancer Research Center, Seattle, WA. Lsehn@bccancer.bc.ca.
2
Laurie H. Sehn, Centre for Lymphoid Cancer, British Columbia Cancer Agency and the University of British Columbia, Vancouver, British Columbia; Tara Baetz, Queen's University, Kingston General Hospital, Kingston; Rena Buckstein, Sunnybrook Health Sciences Center; Michael Crump, Princess Margaret Hospital, University of Toronto, Toronto, Ontario, Canada; Andre Goy and Luis E. Fayad, John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ; Fritz C. Offner, Institute of Hematology and Medical Oncology, University of Bologna; Pier Luigi Zinzani, Institute of Hematology "Seràgnoli" University of Bologna, Bologna; Giovanni Martinelli, European Institute of Oncology, Milano; Gianluca Gaidano, Amedeo Avogadro University of Eastern Piedmont, Novara, Italy; M. Dolores Caballero, University Hospital of Salamanca, Salamanca, Spain; Ole Gadeberg, Vejle Hospital, Vejle, Denmark; Andrew D. Zelenetz, Memorial Sloan Kettering Cancer Center, New York; Jonathan Friedberg, James P. Wilmot Cancer Center, University of Rochester, Rochester, NY; Branimir Jadkisic, Clinical Hospital Merkur, University of Zagreb, Zagreb, Croatia; Swaminathan Padmanabhan Iyer, Houston Methodist Cancer Center, Weill Cornell Medical College, Houston, TX; Deniz Sahin and Günter Fingerle-Rowson, Roche, Basel, Switzerland; Akiko Chai, Genentech BioOncology, South San Francisco, CA; Oliver Press, Fred Hutchinson Cancer Research Center, Seattle, WA.

Abstract

PURPOSE:

Obinutuzumab (GA101), a novel glycoengineered type II anti-CD20 monoclonal antibody, demonstrated responses in single-arm studies of patients with relapsed/refractory non-Hodgkin lymphoma. This is the first prospective, randomized study comparing safety and efficacy of obinutuzumab with rituximab in relapsed indolent lymphoma. The primary end point of this study was the overall response rate (ORR) in patients with follicular lymphoma after induction and safety in patients with indolent lymphoma.

PATIENTS AND METHODS:

A total of 175 patients with relapsed CD20(+) indolent lymphoma requiring therapy and with previous response to a rituximab-containing regimen were randomly assigned (1:1) to four once-per-week infusions of either obinutuzumab (1,000 mg) or rituximab (375 mg/m(2)). Patients without evidence of disease progression after induction therapy received obinutuzumab or rituximab maintenance therapy every 2 months for up to 2 years.

RESULTS:

Among patients with follicular lymphoma (n = 149), ORR seemed higher for obinutuzumab than rituximab (44.6% v 33.3%; P = .08). This observation was also demonstrated by a blinded independent review panel that measured a higher ORR for obinutuzumab (44.6% v 26.7%; P = .01). However, this difference did not translate into an improvement in progression-free survival. No new safety signals were observed for obinutuzumab, and the incidence of adverse events was balanced between arms, with the exception of infusion-related reactions and cough, which were higher in the obinutuzumab arm.

CONCLUSION:

Obinutuzumab demonstrated a higher ORR without appreciable differences in safety compared with rituximab. However, the clinical benefit of obinutuzumab in this setting remains unclear and should be evaluated within phase III trials.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00576758.

PMID:
26282650
PMCID:
PMC5087315
DOI:
10.1200/JCO.2014.59.2139
[Indexed for MEDLINE]
Free PMC Article

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