Gazyva Improves Survival in Follicular Lymphoma Patients
In a phase 3 trial, Gazyva showed superior progression-free survival in previously untreated follicular lymphoma.
Obinutuzumab (Gazyva) demonstrated superior progression-free survival (PFS) compared with rituximab (Rituxan) in previously untreated follicular lymphoma patients.
Gazyva is an engineered monoclonal antibody designed to attach to CD20.The drug is thought to work by attacking targeted cells, both directly and together with the body’s immune system, according to a press release.
The global, open-label, multicenter, randomized, phase 3 GALLIUM study examined the safety and efficacy of Gazyva plus chemotherapy, followed by Gazyva alone for up to 2 years, as compared head-to-head against Rituxan plus chemotherapy, followed by Rituxan alone for up to 2 years.
Data from the pivotal study was presented for the first time during the American Society of Hematology Annual Meeting’s Plenary Scientific Session. This was the third positive phase 3 study for Gazyva, following the CLL11 and GADOLIN studies.
In the study, investigators evaluated 1401 patients with previously untreated indolent non-Hodgkin’s lymphoma (iNHL), of whom 1202 had follicular lymphoma. The primary endpoint was investigator-assessed PFS in patients with follicular lymphoma, with secondary endpoints including PFS as assessed by an independent review committee, PFS in the overall study population (iNHL), response rate (overall response and complete response), overall survival, and safety.
The results of the study showed that the Gazyva-based treatment reduced the risk of disease worsening or death (PFS) by 34% compared with Rituxan-based treatment (HR=0.66; 95% CI 0.51-0.85, p=0.0012). The median PFS was not yet reached.
“Follicular lymphoma, the most common slow-growing form of non-Hodgkin’s lymphoma, is an incurable blood cancer characterized by cycles of remission and disease progression, and becomes harder to treat with every relapse,” said Sandra Horning, MD, chief medical officer and head of Global Product Development for Genentech. “This study of Gazyva-based treatment is the first and only phase 3 trial to date to show superior progression-free survival compared to Rituxan-based treatment, the current standard of care, in previously untreated follicular lymphoma.”