publication date: Aug. 4, 2016

Lymphoma Phase III Gazyva Trial Fails to Meet Primary Endpoint of Improving PFS in DLBCL

 

A phase III study evaluating Gazyva (obinutuzumab) plus CHOP chemotherapy in people with previously untreated diffuse large B-cell lymphoma did not meet its primary endpoint of progression-free survival compared to Rituxan (rituximab) plus CHOP chemotherapy, according to Genentech, a member of the Roche Group.

Adverse events with Gazyva and Rituxan were consistent with those seen in previous clinical trials when each was combined with various chemotherapies. Data from the study, named GOYA, will be presented at an upcoming medical meeting.

“Two previous studies showed Gazyva helped people with previously untreated follicular lymphoma or chronic lymphocytic leukemia live longer without their disease worsening compared to Rituxan, when each was combined with chemotherapy. We were hopeful we could show a similar result for people with diffuse large B-cell lymphoma and once again improve on the standard of care,” said Sandra Horning, chief medical officer and head of Global Product Development. “We will continue to analyze the GOYA data to better understand the results, and to study other investigational treatments in this disease with the goal of further helping these patients.”

GOYA (NCT01287741) was a global, open-label, randomized two-arm study that included 1,418 previously untreated patients with CD20-positive DLBCL.

The primary endpoint of the study was investigator-assessed PFS, with … Continue reading CCL July – Phase III Gazyva Trial Fails to Meet Primary Endpoint of Improving PFS in DLBCL

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