Genentech announced positive results from an interim analysis of the Phase 3 GALLIUM study, evaluating the efficacy of Gazyva (obinutuzumab) plus chemotherapy followed by Gazyva alone in people with previously untreated follicular lymphoma, as compared to Rituxan (rituximab) plus chemotherapy followed by Rituxan alone.
The findings indicated that the Gazyva-based treatment significantly reduced the risk of disease worsening or death. Adverse events were as expected, in both treatment arms. The promising data will be presented at a future medical meeting and submitted to health authorities as part of the portfolio for drug’s approval.
According to the Lymphoma Research Foundation, follicular lymphoma (FL) is the most common slow-growing, or indolent, form of non-Hodgkin lymphoma (iNHL), accounting for 20 percent to 30 percent of all NHLs. Gazyva is a monoclonal antibody engineered to attach to a protein found in certain B-cells, called CD20. Its mechanism of action is thought to be the attack of targeted cells both directly and together with the body’s immune system.
The GALLIUM trial (NCT01332968) is a multi-center, randomized two-arm study to evaluate the efficacy and safety of Gazyva plus chemotherapy, as compared to Rituxan plus chemotherapy, followed by Gazyva or Rituxan alone for up to two years. It included 1,401 patients with previously untreated iNHL, of which 1,202 patients had follicular lymphoma. Its primary endpoint is progression-free survival (PFS) in patients with follicular lymphoma.
In the previous CLL11 study, analysis results showed that Gazyva significantly extended PFS as compared to Rituxan (a median PFS of 26.7 months vs. 14.9 months, respectively).CLL11 (NCT01010061) was the first comparison study of Gazyva and Rituxan plus chemotherapy, conducted in people with previously untreated chronic lymphocytic leukemia. The most common side effects of treatment were infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, nausea and diarrhea. Adverse effects in the GALLIUM clinical trial were consistent with these reported effects.
“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,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in a press release. “GALLIUM is the second study in which Gazyva showed superior progression-free survival compared to Rituxan, when each was combined with chemotherapy.”