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news.Swiss drug-maker Roche has reported positive results from its Phase III trial (GADOLIN) of a monoclonal antibody Gazyva (obinutuzumab) in people with indolent non-Hodgkin’s lymphoma (iNHL) who are refractory to MabThera/Rituxan (rituximab) treatment.
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An independent data monitoring committee determined that the open-label, multicenter, randomized two-arm trial met its primary endpoint early.
Roche chief medical officer and head of Global Product Development Dr Sandra Horning said: "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.
"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."
Around 413 patients with indolent non-Hodgkin’s lymphoma were included in the trial, which evaluated Gazyva plus bendamustine followed by Gazyva alone for up to two years compared to bendamustine alone.
The trial showed that people, who were treated with Gazyva plus bendamustine followed by Gazyva alone, compared to bendamustine alone, lived significantly longer without disease worsening or death (progression-free survival, PFS).
High levels of benefits were seen in the Gazyva arm compared to the bendamustine arm and so the trial was stopped prior to its protocol-specified final analysis.