Positive results from the stage I part of CLL11, a Phase III randomized study shows an improvement in progression-free survival (PFS) and significantly reduced the risk of Chronic Lymphocytic Leukemia (CLL) worsening or death compared to chlorambucil alone.

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. The current standard of care in CD20-positive hematological malignancies is rituximab in combination with chemotherapy or as a single agent.

CLL11 is a Phase III, multi-center, open-lable randomized three-arm study that compares GA101 plus chlorambucil to rituximab (Rituxan?), Rituximab, a therapeutic antibody that binds to a specific protein called CD20 found on the surface of cancerous and normal B-cells, plus chlorambucil or chlorambucil alone. The study includes two separate stages. Stage I evaluated GA101 plus chlorambucil to chlormabucil alone, and included a pre-planned PFS futility analysis comparing GA101 plus chlorambucil to rituximab plus chlorambucil.

Safety and efficacy
The study investigated the safety and efficacy profile of GA101 plus chlorambucil compared to rituximab plus chlorambucil or chlorambucil alone in nearly 800 previously untreated people with CLL and coexisting medical conditions.

The goal of this analysis was to evaluate the likelihood that the study would meet its pre-specified endpoint criteria during Stage II analysis – improved efficacy (PFS) in the direct comparison of GA101 plus chlorambucil to rituximab plus chlorambucil.

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The independent Data and Safety Monitoring Board (DSMB) assessment concluded that Stage II of the study should continue until its final analysis. No new safety events were reported for the GA101 or rituximab containing arms in the study up to the time of this analysis. The study is conducted in close collaboration with the German CLL Study Group (DCLLSG). The primary endpoint of the study is PFS with secondary endpoints including overall response rate (ORR), overall survival (OS), disease free survival (DFS), molecular remission and safety profile.

“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.”

Advanced drug
GA101, one of the most advanced drug candidates in clinical development, 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 rituximab in CLL and non-Hodgkin’s lymphoma (NHL).

Data from CLL11 will be submitted for presentation at an upcoming medical meeting and submitted to European regulatory authorities and the U.S. Food and Drug Administration (FDA) for potential approval.

First approval
Retuximab, discovered by Biogen Idec, first received FDA approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent. It was approved in the European Union under the trade name MabThera in June 1998.
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