Swiss pharmaceutical company Roche has announced that its early Phase III trial of Leukemia drug obinutuzumab (GA101) demonstrated significantly improved progression-free survival in people with chronic lymphocytic leukemia (CLL).
The positive results yield from stage 1 of a three-arm study called CLL11, designed to investigate the efficacy and safety profile of obinutuzumab (GA101) plus chlorambucil, a chemotherapy, compared with chlorambucil alone in people with previously untreated chronic lymphocytic leukemia (CLL).
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This phase of the study met its primary endpoint and an improvement in progression-free survival was achieved; obinutuzumab plus chlorambucil significantly reduced the risk of disease worsening or death compared to chlorambucil alone.
Roche chief medical officer and global product development head Hal Barron said; "the improvement in progression-free survival seen with GA101 is encouraging for people with CLL, a chronic illness of older people for which new treatment options are needed."
"GA101 demonstrates our ongoing commitment to the research and development of new medicines for this disease."
Obinutuzumab is Roche’s most advanced drug in development for the treatment of hematological malignancies.
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By GlobalDataIt has been specifically designed as the first glycoengineered, type 2 anti-CD20 monoclonal antibody in development for B cell malignancies.
In early studies it showed evidence of increased direct cell killing and anti-body dependant cellular cytotoxicity (ADCC).
As a result, GA101’s clinical development programme is designed to show superiority to MabThera / Rituxan, the current standard of care in CLL and non-Hodgkin’s lymphoma (NHL).
Obinutuzumab works by targeting CD20 proteins found on healthy and malignant B lymphocytes (B cells), which die as a result.
Once the cancerous cells are destroyed, the immune system is repopulated with healthy B cells.
Hematological malignancies are cancers of the blood and include chronic lymphocytic leukemia (CLL), indolent non-Hodgkin’s lymphoma (NHL) and diffuse large B-cell lymphoma (DLBCL).
By 2015 it is expected that there will be nearly 225,000 annual deaths worldwide from NHL and nearly 250,000 from leukemia.
Results and data from the CLL11 study will be submitted for presentation to European and other regulatory authorities as well as the US Food and Drug Administration (FDA) for potential marketing approval.
