Genentech has reported that the Phase III GOYA study evaluating Gazyva (obinutuzumab) and CHOP chemotherapy (G-CHOP) in patients with earlier untreated diffuse large B-cell lymphoma (DLBCL) did not meet its primary endpoint.
The primary endpoint is to significantly reduce the risk of disease worsening or death compared to Rituxan (rituximab) plus CHOP chemotherapy (R-CHOP).
The company reported that adverse events with Gazyva and Rituxan were consistent with those seen in earlier clinical trials when each was combined with several chemotherapies.
Genentech global product development head and chief medical officer Sandra Horning said: “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.”
Global Phase III open-label, multicentre, randomised, two-arm study GOYA (NCT01287741) examines the efficacy and safety of the combination of Gazyva along with CHOP chemotherapy (G-CHOP), compared to Rituxan and CHOP chemotherapy (R-CHOP).
The study included 1,418 previously untreated patients with CD20-positive DLBCL.
Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found on certain types of B-cells.
It is believed to work by attacking targeted cells both directly and together with the body's immune system.
Gazyva was discovered by Roche Glycarta wholly owned, independent research unit of Roche.
Within the US, Gazyva is part of a collaboration between Roche Group member Genentech, and Biogen.