For patients with untreated follicular lymphoma (FL), obinutuzumab with chemotherapy can result in more clinically meaningful improvements in progression-free survival (PFS), durable efficacy, and manageable safety compared with rituximab with chemotherapy, according to research presented at the ASCO20 Virtual Scientific Program.
Previously, researchers conducted a phase 3, multicenter, randomized analysis (GALLIUM; ClinicalTrials.gov Identifier: NCT01332968) of patients with untreated FL to determine the efficacy and safety of obinutuzumab, a glycoengineered type 2 anti-CD20 monoclonal antibody (mAb), compared with rituximab immunochemotherapy followed by mAb treatment alone. The findings from GALLIUM suggested significant improvements in favor of obinutuzumab.
In a new study, investigators reported the 5-year updated efficacy and safety results from the GALLIUM study. Some participant eligibility requirements included an age of 18 years of older, advanced stage disease, and previously untreated grade 1 to 3a FL. A total of 1202 patients were included in the analysis (median age, 59 years); 601 patients were randomly assigned (1:1 ratio) to receive either 1000 mg intravenous (IV) obinutuzumab or 375 mg/m2 IV of rituximab with chemotherapy for 6 to 8 cycles. Chemotherapy was type not randomized and was decided per treatment center. Patients who responded to treatment received maintenance therapy with the same mAb every 2 months for 2 years. Median follow-up was 76.5 months.
Patients receiving obinutuzumab showed improvements in 5-years PFS compared with patients receiving rituximab (hazard ratio, 0.76; P =.0043; 70.5% vs 63.2%). Overall survival was not significantly different between both groups of patients. Time to next treatment was greater for patients treated with obinutuzumab.
In addition, the frequency of grade 3 to 5 adverse events was higher in the obinutuzumab group compared with the rituximab group (79.3% vs 71.2%, respectively). These results were consistent with previous analyses.
“These data further demonstrate the clinically meaningful and durable benefit of treatment with [obinutuzumab with chemotherapy] relative to [rituximab with chemotherapy] in previously untreated FL [patients],” the authors concluded.
Disclosure: This clinical trial was supported by F. Hoffmann-La Roche Ltd. Please see the original reference for a full list of author’s disclosures.
Townsend W, Buske C, Cartron G, et al. Comparison of efficacy and safety with obinutuzumab plus chemotherapy versus rituximab plus chemotherapy in patients with previously untreated follicular lymphoma: updated results from the phase III Gallium Study. Presented at: ASCO20 Virtual Scientific Program. J Clin Oncol. 2020;38(suppl):abstr 8023.
This article originally appeared on Hematology Advisor