Positive data from GALLIUM study presented at ASH for obinutuzumab + chemotherapy shows improved PFS for follicular lymphoma.- Genentech + Roche

Data from the Phase III GALLIUM study (Abstract #6), presented at the American Society of Hematology (ASH) annual congress, demonstrate that obinutuzumab in combination with chemotherapy, from Genentech/Roche met its progression free survival (PFS) endpoint, with a 34% reduction in the risk of disease progression or death in patients with previously untreated follicular lymphoma (FL). This was compared to the current standard-of-care, rituximab (MabThera) plus chemotherapy (HR, 0.66; 95% CI, 0.51, 0.85; p=0.001).

At a pre-planned interim analysis in May 2016, an independent data monitoring committee determined that the study met its primary endpoint early. Time to next anti-lymphoma treatment (TTNT) was extended by 32% in patients receiving obinutuzumab plus chemotherapy compared to rituximab plus chemotherapy (HR, 0.68; 95% CI, 0.51, 0.91; p=0.009).Whilst there were no new adverse events, the most common severe (grade 3) side-effects associated with obinutuzumab-based treatment in comparison to rituximab-based therapy, include infections (20.0% vs 15.6%), infusion-related reactions (IRRs) (12.4% vs 6.7%) and second neoplasms (4.7% vs 2.7%). Additionally, an analysis of minimal residual disease (MRD) status in the GALLIUM study (Abstract #613) was also presented. Results show that at the end of initial therapy, 92% of patients receiving obinutuzumab in combination with chemotherapy, showed no detectable sign of disease in the blood or bone marrow, compared to 85% of patients receiving the rituximab plus chemotherapy combination (p=0.0041).