Gazyva fails to meet primary endpoint in Phase 3 trial

SOUTH SAN FRANCISCO, Calif.—Genentech, a member of the Roche Group, announced July 18 that the Phase 3 GOYA study evaluating Gazyva (obinutuzumab) plus CHOP chemotherapy (G-CHOP) in people with previously untreated diffuse large B cell lymphoma (DLBCL) did not meet its primary endpoint of significantly reducing the risk of disease worsening or death (progression-free survival) compared to Rituxan (rituximab) plus CHOP chemotherapy (R-CHOP). Adverse events with Gazyva and Rituxan were consistent with those seen in previous clinical trials when each was combined with various chemotherapies.

“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 Dr. Sandra Horning, Genentech’s 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 is a global Phase 3 open-label, multicenter, randomized two-arm study examining the efficacy and safety of G-CHOP compared to R-CHOP. GOYA included 1,418 previously untreated patients with CD20-positive DLBCL. The primary endpoint of the study is investigator-assessed progression-free survival, with secondary endpoints including progression-free survival assessed by independent review committee, overall response, complete response, overall survival, disease-free survival and safety profile.

DLBCL is the most common form of non-Hodgkin’s lymphoma (NHL), accounting for about one in three cases of NHL. DLBCL is an aggressive type of NHL. As many as 40 percent of patients will relapse, at which point their prognosis is poor. In the United States, it is estimated that more than 24,000 new cases of DLBCL will be diagnosed in 2016.

Gazyva is an engineered monoclonal antibody designed to attach to CD20, a 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.