GALLIUM: obinutuzumab for the first-line treatment of follicular lymphoma
Obinutuzumab with chemotherapy and as maintenance kept follicular lymphoma from progressing for longer than rituximab, at the cost of more serious side effects.
Overview
Open-label phase 3 trial: 1,202 patients with previously untreated follicular lymphoma were randomised to obinutuzumab or rituximab with bendamustine, CHOP or CVP, followed by antibody maintenance.
At a planned interim analysis after a median follow-up of 34.5 months, estimated three-year progression-free survival was 80.0 percent with obinutuzumab against 73.3 percent with rituximab (hazard ratio 0.66). Response rates were similar (88.5 against 86.9 percent); grade 3 to 5 adverse events (74.6 against 67.8 percent) and serious adverse events (46.1 against 39.9 percent) were more frequent with obinutuzumab, and infusion-related events were the most common adverse event.
- Three-year progression-free survival 80.0 versus 73.3 percent; hazard ratio 0.66 (95% CI 0.51 to 0.85), p 0.001.
- Overall response 88.5 versus 86.9 percent.
- Grade 3 to 5 adverse events 74.6 versus 67.8 percent; deaths from adverse events 4.0 versus 3.4 percent.
Obinutuzumab-based immunochemotherapy is a first-line option for follicular lymphoma; the choice against rituximab weighs longer progression-free survival against toxicity and cost.
- No overall survival difference; toxicity was highest with bendamustine partners.
- Open-label design with investigator-assessed primary endpoint, supported by independent review.
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