Phase III GALLIUM trial shows Gazyva (obinutuzumab) improves progression free survival versus Rituxan in follicular lymphoma- Genentech/Roche
Genentech/Roche have 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), which compared the efficacy and safety of 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 (in terms of progression-free survival) compared to Rituxan-based treatment. Adverse events with either Gazyva or Rituxan were consistent with what was seen in previous clinical trials when each was combined with various chemotherapies. Data from the GALLIUM study will be presented at an upcoming medical meeting and submitted to health authorities for approval consideration.
Comment: Gazyvaro was first authorised in the European Union (EU) in July 2014 for use in combination with chlorambucil in patients with previously untreated chronic lymphocytic leukaemia.
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