Gazyva (obinutuzumab) plus bendamustine results of Phase III GADOLIN study in non-Hodgkin's lymphoma- Genentech + Roche

Genentech, a member of the Roche Group announced results from the Phase III GADOLIN study showing that Gazyva (obinutuzumab) plus bendamustine followed by Gazyva alone provided significant benefit for people with indolent non-Hodgkin’s lymphoma (NHL) that is refractory to Rituxan (rituximab)-based treatment. In the study, Gazyva plus bendamustine followed by Gazyva alone reduced the risk of disease worsening or death (progression-free survival, PFS) by 45 percent (HR=0.55, p=0.0001), compared to bendamustine alone. The study was stopped prior to its protocol-specified final analysis due to the high level of benefit seen in the Gazyva arm compared to the bendamustine arm. There were no unexpected safety signals identified with Gazyva.

Results presented at ASCO showed: The median PFS was not reached in the Gazyva-based treatment group versus 14.9 months with bendamustine alone (HR=0.55, p=0.0001) as assessed by IRC. The median PFS with Gazyva-based treatment was more than double that with bendamustine alone (29.2 months vs. 14.0 months, HR=0.52, p<0.0001), as assessed by investigator review. No unexpected safety signals were identified in the Gazyva-based treatment arm. Grade 3-4 adverse events occurred in at least two percent of patients in the Gazyva-treated group or bendamustine alone group.