Gazyva Shows Superior Progression-Free Survival in Follicular Lymphoma
Obinutuzumab (Gazyva) is an engineered monoclonal antibody designed to attach to the CD20 protein.
A pivotal phase 3 study of obinutuzumab (Gazyva) showed superior progression-free survival compared with rituximab (Rituxan) in previously untreated patients with follicular lymphoma.
Gazyva is an engineered monoclonal antibody designed to attach to the CD20 protein. Researchers believe it works by attacking targeted cells directly, as well in combination with the immune system.
The open-label, multicenter, randomized, 2 arm, global phase 3 clinical trial GALLIUM studied the safety and efficacy of Gazyva plus chemotherapy followed by Gazyva alone versus Rituxan plus chemotherapy followed by Rituxan alone. The chemotherapies used in the study were CHOP, CVP, or bendamustine.
The study enrolled 1401 patients with previously untreated indolent non-Hodgkin’s lymphoma (iNHL), 1202 of whom had follicular lymphoma.
The study was assessed by an independent review committee that determined the primary endpoint of progression free survival (PFS) in follicular lymphoma patients, and secondary endpoints including PFS in the overall study population (iNHL), response rate (overall response rate and complete response), overall survival (OS), disease-free survival (DFS), and safety.
“People with follicular lymphoma continue to need better initial treatment options because their disease is incurable and becomes more difficult to treat with each relapse,” said Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech. “GALLIUM is the second study in which Gazyva showed superior progression-free survival compared to Rituxan, when each was combined with chemotherapy.”
The first study comparing Gazyva and Rituxan called CLL11 included patients with previously untreated chronic lymphocytic leukemia.
The CLL11 study showed that Gazyva plus chlorambucil significantly extended PFS compared with Rituxan plus chlorambucil (median PFS 26.7 months vs. 14.9 months, respectively; HR=0.42; 95% CI, 0.33-0.54; p<0.0001).
The most common adverse effects of combination Gazyva plus chlorambucil included low white blood cell counts, low red blood cell counts, low platelet counts, infusion reactions, cough, diarrhea, fever, and nausea.