February 4, 2015
By Jessica Wilson, BioSpace.com Breaking News Staff
Genentech announced on Tuesday positive results from its Phase III study of Gazyva (obinutuzumab) plus bendamustine for the treatment of patients with indolent non-Hodgkin’s lymphoma (iNHL) who have developed resistance to Rituxan (rituximab) treatment.
An independent data monitory committee analyzed the results of the study, named GADOLIN, and found that patients lived significantly longer without disease worsening, or death, when treated with Gazyva plus bendamustine followed by Gazyva alone as compared to bendamustine alone. In addition, Gazyva did not cause “unexpected adverse events,” according to the company’s press release.
GADOLIN involved 413 patients with iNHL who had not responded to Rituxan-based therapy, as measured by disease progression during or following treatment with Rituxan. GADOLIN was an open-label, multicenter, randomized two-arm study meant to evaluate patients who received Gazyva plus bendamustine followed by Gazyva alone for up to two years compared to patients who received bendamustine alone. The primary endpoint of the study was progression free survival (PFS), with secondary endpoints including response rate (RR), best response and overall survival (OS). Because patients in the Gazyva arm of the study experience such a high level of benefit as compared to patients in the bendamustine arm, researchers stopped the study.
“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 Rituxan-based therapy failed to adequately control their disease,” said Sandra Horning, chief medical officer and head of global product development at Genentech, a member of the Roche Group, in a statement.
The company will submit data from the study for presentation at an upcoming medical meeting and for approval to various health authorities, including the U.S. Food and Drug Administration (FDA).
The U.S. FDA first approved Gazyva in November 2013; therefore, Genentech will be applying for approval of a second indication for the drug. The FDA initially approved the drug for use by patients with previously untreated chronic lymphocytic leukemia (CLL). In addition, Gazyva was the first medicine approved with the FDA’s Breakthrough Therapy Designation.
At the time of the approval, Genentech emphasized the success rate of the drug. “As based on clinical data, it [Gazyva] more than doubled the time people lived without their disease worsening compared to chlorambucil alone,” said Hal Barron, then-chief medical officer and head of global product development. “We have spent 20 years researching blood cancer medicines, and we will continue to study Gazyva to assess its efficacy in other types of blood cancers.”
With the announcement of the positive results from GADOLIN, Genentech has followed-up on the plans announced by Barron. “GADOLIN is the first of our pivotal Phase III studies of Gazyva to be completed in the non-Hodgkin’s lymphoma setting,” Horning said yesterday. Several others are in progress.
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