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 secondary endpoints including PFS assessed by independent review committee; overall response and complete response rates; overall survival; disease free survival; and safety profile. The GOYA study is being conducted in cooperation with the Fondazione Italiana Linfomi.
Gazyva is an engineered monoclonal antibody designed to attach to the CD20 protein found on certain types of B-cells. It is thought to work by attacking targeted cells both directly and together with the body’s immune system. Gazyva was discovered by Roche Glycart AG, a wholly owned, independent research unit of Roche. In the United States, Gazyva is part of a collaboration between Genentech and Biogen.
Combination studies investigating Gazyva with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are planned or underway across a range of blood cancers.
Gazyva is approved in the U.S. with chlorambucil to treat chronic lymphocytic leukemia in adults who have not had previous CLL treatment—and also in combination with bendamustine, followed by Gazyva alone, for follicular lymphoma in adults who did not respond to a rituximab-containing regimen, or whose disease returned after such treatment.
