Gazyva Does Not Meet Primary Endpoint in Lymphoma Trial

Obinutuzumab not found to improve progression-free survival in untreated diffuse large B-cell lymphoma.

A phase 3 study evaluating obinutuzumab (Gazyva) plus CHOP chemotherapy (G-CHOP) in people with previously untreated diffuse large B-cell lymphoma (DLBCL) did not meet its primary endpoint.

The global, open-label, multicenter, randomized phase 3 study GOYA (NCT01287741) evaluated the safety and efficacy of G-CHOP compared with Rituxan plus CHOP chemotherapy (R-CHOP).

Gazyva is an engineered monoclonal antibody that attaches to CD20, and is designed to attack targeted cells both directly and together with the immune system.

For the GOYA study, researchers enrolled 1418 previously untreated patients with CD20-positive DLBCL. The primary endpoint was investigator-assessed progression-free survival (PFS), while the secondary endpoints were assessed by an independent review committee (IRC) to determine PFS, response rate (overall response [ORR]; and complete response, [CR]), overall survival (OS), disease free survival (DFS), and safety profile.

The results of the study, which will be presented at an upcoming medical meeting, showed that G-CHOP did not meet the primary endpoint of significantly reducing the risk of PFS compared with R-CHOP. The adverse events of Gazyva and Rituxan were consistent with findings from previous clinical trials that combined the drugs 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,” said Sandra Horning, MD, chief medical officer, head of Global Product Development at Genentech. “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. 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.”

In the United States, its estimated that more than 24,000 new cases of DLBCL will be diagnosed in 2016, and as many as 40% of patients will relapse, resulting in a poor prognosis.