Success for Gazyva (obinutuzumab) + bendamustine in Phase III GADOLIN study for NHL- Genentech+ Roche

Genentech, a member of the Roche Group has announced positive results from the Phase III GADOLIN study, which evaluated treatment options for people with indolent non-Hodgkin�s Lymphoma (iNHL) who are refractory to Rituxan (rituximab) treatment. At a pre-planned interim analysis, an independent data monitoring committee determined that the study met its primary endpoint early. The study showed that people lived significantly longer without disease worsening or death (progression-free survival; PFS) when treated with Gazyva (obinutuzumab) plus bendamustine followed by Gazyva alone, 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 adverse events with Gazyva.

GADOLIN (NCT01059630; GA04753g) is a Phase III open-label, multicenter, randomized two-arm study evaluating Gazyva plus bendamustine followed by Gazyva alone for up to two years compared to bendamustine alone in 413 patients with indolent non-Hodgkin�s lymphoma whose disease progressed during or following Rituxan-based therapy. The primary endpoint of the study is PFS, with secondary endpoints including response rate (RR), best response and overall survival (OS).

Comment: Pharmacyclics and Roche have entered into a clinical drug supply agreement to evaluate the safety, tolerability and preliminary efficacy of Imbruvica (ibrutinib) in combination with Gazyva (obinutuzumab) in patients with non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma (CLL/SLL).