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 Journal Article


Authors: Sehn, L. H.; Goy, A.; Offner, F. C.; Martinelli, G.; Caballero, M. D.; Gadeberg, O.; Baetz, T.; Zelenetz, A. D.; Gaidano, G.; Fayad, L. E.; Buckstein, R.; Friedberg, J. W.; Crump, M.; Jaksic, B.; Zinzani, P. L.; Iyer, S. P.; Sahin, D.; Chai, A.; Fingerle-Rowson, G.; Press, O. W.
Article Title: 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
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. (C) 2015 by American Society of Clinical Oncology
Keywords: cyclophosphamide; follicular lymphoma; advanced; monoclonal-antibody therapy; low-grade; progression-free survival; chronic lymphocytic-leukemia; increases; significantly; prolongs survival; maintenance treatment; anti-cd20 antibody
Journal Title: Journal of Clinical Oncology
Volume: 33
Issue: 30
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2015-10-20
Start Page: 3467
End Page: 3474
Language: English
ACCESSION: WOS:000366019300019
DOI: 10.1200/jco.2014.59.2139
PROVIDER: wos
PUBMED: 26282650
PMCID: PMC5087315
Notes: Article -- Source: Wos
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MSK Authors
  1. Andrew D Zelenetz
    551 Zelenetz