Posted on June 8th, 2016 by
Genentech, announced positive results from the pivotal Phase III GALLIUM study in people with previously untreated follicular lymphoma, the most common type of indolent (slow-growing) non-Hodgkin’s lymphoma (iNHL). The study compared Gazyva® (obinutuzumab) plus chemotherapy (CHOP, CVP or bendamustine) followed by Gazyva alone, head-to-head with Rituxan® (rituximab) plus chemotherapy followed by Rituxan alone. Results from a pre-planned interim analysis showed that Gazyva-based treatment significantly reduced the risk of disease worsening or death compared to Rituxan-based treatment.
Follicular lymphoma is the most common indolent form of non-Hodgkin’s lymphoma (NHL), accounting for about one in five cases of NHL. It is considered incurable and relapse is common. In the United States, it is estimated that more than 14,000 new cases of follicular lymphoma will be diagnosed in 2016.
Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found on certain types of B-cells. It is thought to work by attacking targeted cells both directly and together with the body’s immune system.
GALLIUM is a global comparative clinical trial examining 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. GALLIUM included 1,401 patients with previously untreated iNHL, of which 1,202 patients had follicular lymphoma.
In a previous comparison of Gazyva and Rituxan people with previously untreated chronic lymphocytic leukemia, Gazyva plus chlorambucil significantly extended PFS compared to treatment with Rituxan plus chlorambucil.2 The results of the GALLIUM will be presented in total at an upcoming medical meeting.
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