Abstract
In patients with rituximab refractory indolent B cell lymphoma, the treatment options are limited. Bendamustine has a 9 months median progression free survival (PFS) and 10 months response duration in phase II trials.
The combination of bendamustine (90 mg/m2 on days 1-2) with new monoclonal antibody anti CD20 - obinutuzumab - GA101 (1,000 mg on days 1, 8, 15 in cycle 1 and 1,000 mg on day 1 in cycles 2-6) was compared to the monotherapy with higher dose of bendamustine (120 mg/m2 on days 1-2, maximum of 6 cycles) in a randomised phase III study GADOLIN with 396 patients. Patients in the combination arm without progression after induction therapy were treated with obinutuzumab as a maintenance therapy every 2 months for 2 years.
Progression free survival (PFS) was the primary endpoint of the study. With median follow up of 20 months, PFS assessed by investigators in the bendamustine arm was 14 months compared to 29 months in the combination arm (p<0.0001).
The combination of obinutuzumab with bendamustine seems to be one of the most efficient treatments for this cohort of patients with unfavourable prognosis.