Patients with previously untreated diffuse large B-cell lymphoma (DLBCL) given Gazyva/Gazyvaro (obinutuzumab) plus standard chemotherapy (CHOP) do not have higher progression-free survival rates than those treated with Rituxan/MabThera (rituximab), according to new data from the Phase 3 GOYA study. The trial’s results will soon be presented at a medical meeting.
“Two previous studies showed Gazyva/Gazyvaro helped people with previously untreated follicular lymphoma or chronic lymphocytic leukaemia live longer without their disease worsening compared to MabThera/Rituxan, when each was combined with chemotherapy,” Sandra Horning, MD, chief medical officer and head of Global Product Development at Roche, said in a press release. “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.”
Obinutuzumab is a monoclonal antibody that targets the CD20 protein, expressed at the surface of certain B-cells, but not stem cells or plasma cells.
The combination of obinutuzumab plus chlorambucil is currently approved in more than 70 countries after results from the CLL11 Phase 3 study, where this combination was found to significantly improve progression-free survival (PFS), overall response rate, complete response rate, and minimal residual disease in patients with chronic lymphocytic leukemia, compared to rituximab plus chlorambucil.
Early this year, the U.S. Food and Drug Administration (FDA) also approved obinutuzumab, known as Gazyva in the U.S., in combination with bendamustine followed by obinutuzumab maintenance for follicular lymphoma patients who did not respond to a therapy regimen containing rituximab. Similarly, obinutuzumab received a similar approval by the European Commission, where it is known as Gazyvaro, in June 2016.
Researchers developed the randomized, open-label, multicenter GOYA study to examine the efficacy of obinutuzumab plus CHOP (cyclophosphamide, hydroxydaunorubicin, oncovin, prednisone) chemotherapy (a treatment called G-CHOP), compared to rituximab plus CHOP (R-CHOP), in patients with untreated DLBCL.
The study enrolled 1,418 patients with CD20-positive untreated DLBCL and its primary endpoint was investigator-assessed PFS. Secondary endpoints included independent review committee-assessed PFS, overall response rate, complete response rate, overall survival, disease free survival, and safety profile.
Preliminary results announced by Roche reveal that the study did not meet its primary endpoint of improved PFS in patients treated with G-CHOP versus R-CHOP. Adverse events in both arms were similar to those obtained in previous studies were obinutuzumab and rituximab were combined with other chemotherapies, the data shows.
“We will continue to analyse 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,” Horning concluded.