Genentech leukaemia drug meets primary endpoint in phase 3

Hannah Blake

pharmaphorum

Genentech, a member of the Roche Group, has announced positive results from stage 1 of phase 3 clinical trials of investigational leukemia drug, obinutuzumab (GA101) plus chlorambucil chemotherapy. In the trials, obinutuzumab has been 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.

GA101 has been specifically designed as the first glycoengineered, type 2 anti-CD20 monoclonal antibody in development for B-cell malignancies.

"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."

Hal Barron, M.D., chief medical officer and head, Global Product Development.

Hematological malignancies are cancers of the blood and include CLL, indolent NHL and diffuse large B-cell lymphoma (DLBCL). In 2013, it is expected that there will be nearly 19,020 annual deaths from NHL and nearly 4,580 annual deaths from CLL in the United States.