Genentech announced positive results from the pivotal Phase 3 GALLIUM study evaluating a head-to-head comparison of Gazyva (obinutuzumab) vs. Rituxan (rituximab) for the treatment of patients with previously untreated follicular lymphoma, the most common type of indolent non-Hodgkin’s lymphoma (iNHL).
The GALLIUM study is a global, open-label, multicenter, randomized, two-arm, Phase 3 study evaluating the efficacy and safety of Gazyva (obinutuzumab) plus chemotherapy (CHOP, CVP or bendamustine) followed by Gazyva alone compared to Rituxan (rituximab) plus chemotherapy followed by Rituxan alone in patients with previously untreated iNHL for up to 2 years. The primary endpoint was investigator-assessed progression-free survival (PFS) in patients with follicular lymphoma. Secondary endpoints included PFS assessed by independent review committee (IRC), PFS in the overall study population (iNHL), response rate (overall response, ORR; and complete response, CR), overall survival (OS), disease-free survival (DFS) and safety.
Results from the pre-planned interim analysis showed that patients treated with a Gazyva-based regimen had a significant reduction in the risk of disease worsening or death (PFS) compared to a Rituxan-based regimen. Adverse events observed for either Gazyva or Rituxan regimens were consistent with results from previous clinical trials. Detailed study data will be presented at an upcoming medical meeting and submitted to regulatory agencies for approval.
Gazyva is a CD20-directed cytolytic monoclonal antibody currently indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL), in combination with chlorambucil, and for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen, in combination with bendamustine followed by Gazyva monotherapy.
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