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On 2 October 2018, Jeff P. Sharman from the Willamette Valley Cancer Institute and Research Center, Oregon, USA and colleagues, published in Leukemia & Lymphoma the final analysis of the phase II trial GATHER (NCT01414855). In this open-label, multicenter study, the efficacy and safety of obinutuzumab (RO5072759 [GA101]) in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) chemotherapy in patients with advanced diffuse large B-cell lymphoma (DLBCL) was evaluated.
DLBCL is one of the most common lymphomas and with the current standard of care (rituximab and CHOP), approximately 60% of patients are cured or improve. Nevertheless, there is still 40% of patients who remain uncured. Obinutuzumab is a glycoengineered, humanized, type 2 anti-CD20 monoclonal antibody with high anti-tumor activity. In this phase II trial, the safety and efficacy of obinutuzumab in combination with CHOP (G-CHOP) was investigated, with a minimum of three years follow-up, in newly-diagnosed advanced DLBCL patients. The primary outcomes of the study were overall response rate (ORR) and complete response (CR) rates calculated by investigator assessment, while secondary outcomes included independent review of ORR and CR, as well as progression-free survival (PFS) and overall survival (OS). The importance of the cell of origin (COO) on the efficacy and safety of a shorter duration infusion of obinutuzumab was also evaluated in this study.
The phase II GATHER trial demonstrated that G-CHOP is a safe first-line treatment with good efficacy for patients with advanced DLBCL. The authors stated that despite the fact that initial obinutuzumab administration was frequently associated with IRRs, following the first infusion IRRs were uncommon, mild and manageable.
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