Roche’s Phase III study of Gazyva/Gazyvaro showed significant benefit in refractory indolent non-Hodgkin’s lymphoma

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today 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 MabThera®/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 is the first of our pivotal Phase III studies of Gazyva to be completed in the non-Hodgkin’s lymphoma setting, building on the positive results we have seen in chronic lymphocytic leukemia,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are delighted that this study could be evaluated early due to the strength of its data, which we believe supports Gazyva’s potential in combination with bendamustine for people whose MabThera/Rituxan-based therapy failed to adequately control their disease.”

Data from this pivotal study will be submitted for presentation at an upcoming medical meeting and to the U.S. Food and Drug Administration, European Medicines Agency and other health authorities around the world for approval consideration.