Genentech announced positive results from Stage 1 of CLL11, a Phase 3 randomized study to investigate the efficacy and safety profile of the investigational medication obinutuzumab (GA101) plus chlorambucil chemotherapy compared to chlorambucil alone in previously untreated Chronic Lymphocytic Leukemia (CLL). GA101 is the first glycoengineered, type 2 anti-CD20 monoclonal antibody in development for B-cell malignancies. It targets CD20 proteins found on B-cells and is designed to result in cell death.
CLL11 is a multicenter, open-label, randomized, three-arm study investigating the safety and efficacy profile of GA101 plus chlorambucil compared to Rituxan plus chlorambucil or chlorambucil alone in about 800 previously untreated people with CLL and coexisting medical conditions. The primary endpoint of CLL11 is progression-free survival (PFS). An improvement in PFS was achieved as GA101 plus chlorambucil significantly reduced the risk of disease worsening or death compared to chlorambucil alone.
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