Genentech announces positive results from GA101 plus chlorambucil Phase III study on CLL

Published on January 31, 2013 at 3:05 AM · No Comments

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from Stage 1 of CLL11, a Phase III randomized study to investigate the efficacy and safety profile of the investigational medicine obinutuzumab (GA101) plus chlorambucil chemotherapy compared with chlorambucil alone in people with previously untreated chronic lymphocytic leukemia (CLL). An improvement in progression-free survival (PFS) was achieved as GA101 plus chlorambucil significantly reduced the risk of disease worsening or death compared to chlorambucil alone.

"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," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "GA101 demonstrates our ongoing commitment to the research and development of new medicines for this disease."

GA101 has been specifically designed as the first glycoengineered, type 2 anti-CD20 monoclonal antibody in development for B-cell malignancies. In pre-clinical development, GA101 has shown evidence of increased direct cell killing and antibody-dependent cellular cytotoxicity (ADCC). As a result, GA101's clinical development program is designed to assess whether or not it is superior to Rituxan® (rituximab) in CLL and non-Hodgkin's lymphoma (NHL).

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