GOYA Study of G-CHOP Fails to Meet Primary End Point
The phase 3 GOYA study for patients with previously untreated diffuse large B-cell lymphoma (DLBCL) failed to meet its primary endpoint.
The phase 3 GOYA study, which evaluated the efficacy and safety of obinutuzumab (Gazyva) plus CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) for patients with previously untreated diffuse large B-cell lymphoma (DLBCL), failed to meet its primary endpoint of progression-free survival improvement, according to an announcement by Genentech.1
This drug regimen was contrasted with rituximab plus CHOP. Safety profiles of both regimens, however, were consistent with previously reported clinical trials.
Obinutuzumab is indicated for the treatment of previously untreated chronic lymphocytic leukemia, in combination with chlorambucil, and for rituximab-refractory follicular lymphoma with bendamustine.
"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 and head of Global Product Development at Genentech.
For this multicenter, open-label, phase 3 trial, researchers enrolled 1418 treatment-naive patients with CD20-positive DLBCL. Participants were randomly assigned to receive CHOP chemotherapy with either obinutuzumab or rituximab.
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"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," said Dr Horning.
- Genentech provides update on phase III study of Gazyva in people with previously untreated diffuse large B-cell lymphoma [news release]. South San Francisco, CA: Genentech; July 17, 2016. http://www.gene.com/media/press-releases/14633/2016-07-17/genentech-provides-update-on-phase-iii-s. July 19, 2016.