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BACKGROUND: Rituximab-based immunochemotherapy has improved outcomes in patients with follicular lymphoma. Obinutuzumab is a glycoengineered type II anti-CD20 monoclonal antibody. We compared rituximab-based chemotherapy with obinutuzumab-based chemotherapy in patients with previously untreated advanced-stage follicular lymphoma. METHOD(S): We randomly assigned patients to undergo induction treatment with obinutuzumab-based chemotherapy or rituximab-based chemotherapy. Patients with a response received maintenance treatment for up to 2 years with the same antibody that they had received in induction. The primary end point was investigator-assessed progression-free survival. RESULTS: A total of 1202 patients with follicular lymphoma underwent randomization (601 patients in each group). After a median follow-up of 34.5 months (range, 0 to 54.5), a planned interim analysis showed that obinutuzumab-based chemotherapy resulted in a significantly lower risk of progression, relapse, or death than rituximab-based chemotherapy (estimated 3-year rate of progression-free survival, 80.0% vs. 73.3%; hazard ratio for progression, relapse, or death, 0.66; 95% confidence interval [CI], 0.51 to 0.85; P=0.001). Similar results were seen with regard to independently reviewed progression-free survival and other time-to-event end points. Response rates were similar in the two groups (88.5% in the obinutuzumab group and 86.9% in the rituximab group). Adverse events of grade 3 to 5 were more frequent in the obinutuzumab group than in the rituximab group (74.6% vs. 67.8%), as were serious adverse events (46.1% vs. 39.9%). The rates of adverse events resulting in death were similar in the two groups (4.0% in the obinutuzumab group and 3.4% in the rituximab group). The most common adverse events were infusion-related events that were considered by the investigators to be largely due to obinutuzumab in 353 of 595 patients (59.3%; 95% CI, 55.3 to 63.2) and to rituximab in 292 of 597 patients (

Obinutuzumab (G) is a glycoengineered type II anti-CD20 monoclonal antibody with promising activity and manageable toxicity when combined with chemotherapy in relapsed iNHL. GALLIUM (NCT01332968) is an open-label, randomised Phase 3 study comparing the efficacy and safety of rituximab (R) or G with chemotherapy followed by maintenance as first-line treatment in iNHL. Patients (pts) were aged >=18 years with previously untreated follicular lymphoma (FL) (grades 1-3a) or chemotherapy-nave marginal zone lymphoma (MZL), stage III/IV disease or stage II with tumour diameter >=7 cm, ECOG PS 0-2, and requiring treatment according to GELF criteria. CHOP, CVP, or bendamustine (B) were allocated according to centre (FL) or pt (MZL). Pts were randomised 1:1 and stratified by chemotherapy, FLIPI/IPI group, and geographic region to receive R 375 mg/m2 on D1 of each cycle or G 1000 mg on D1, 8, 15 of Cycle 1 and D1 of subsequent cycles, for either 8 x 21-day cycles (CHOP, CVP) or 6 x 28-day cycles (B). Pts with a CR or PR at the end of induction (EOI) received R or G every 2 months for 2 years or until disease progression. The primary endpoint was investigator-assessed PFS in FL pts. The current data are from an interim efficacy analysis done when a planned 67% of 370 PFS events had occurred (cut-off date: Jan 31, 2016) after which the study was unblinded on IDMC recommendation. Results are reported for 1202 FL pts (R-chemo, 601; G-chemo, 601); median age 59 years, 53.2% female. Treatment arms were well balanced by disease stage (Ann Arbor: I, 1.5%; II, 7.1%; III, 34.9%; IV, 56.5%) and prognostic factors (FLIPI: 0 + 1, 21.0%; 2, 37.2%; >=3, 41.8%; FLIPI-2: 0, 9.1%; 1 + 2, 50.3%; >=3, 40.6%). 686 patients (57.1%) received B, 33.1% CHOP, and 9.8% CVP. CR and ORR at EOI were similar for the two arms. There was a 34% reduction in the risk of progression or death (HR 0.66; 95% CI, 0.51-0.85; p = 0.001; median follow-up 34.5 months, range 0-54.5). Although the median PFS has not been r