Wednesday, January 30, 2013

Obinutuzumab (GA101) a follow on to Roche's lead drug Mabthera demonstrates improvement in PFS in people with Chronic Lymphocytic Leukemia

Roche has 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, a chemotherapy, compared with chlorambucil alone in people with previously untreated chronic lymphocytic leukemia (CLL). Obinutuzumab is designed to replace Mabthera, which currently generates approximately $6b in annual sales for Roche. A superior outcome of Obinutuzumab could mean a blow for companies that are currently working to develop a biosimilar copy of Roche's Rituximab.
The 1st stage of this phase III study met its primary endpoint and an additional futility analysis suggested that GA101 could show superiority compared to MabThera/Rituxan in first line CLL.

CLL11 is a three-arm study that compares GA101 plus chlorambucil to MabThera/Rituxan plus chlorambucil or chlorambucil alone. The study includes two separate stages.
Stage 1 evaluated GA101 plus chlorambucil to chlorambucil alone, and included a pre-planned PFS futility analysis comparing GA101 plus chlorambucil to MabThera/Rituxan plus chlorambucil. The goal of this futility analysis was to evaluate the likelihood that the study would meet its pre-specified endpoint criteria during stage 2 analysis – improved efficacy (PFS) in the direct comparison of GA101 plus chlorambucil to MabThera/Rituxan plus chlorambucil. The independent Data and Safety Monitoring Board (DSMB) assessment concluded that stage 2 of the study should continue until its final analysis. No new safety events were reported for the GA101 or MabThera/Rituxan containing arms in the study up to the time of this analysis.

Data from CLL11 will be submitted for presentation at an upcoming medical meeting and submitted to European and other regulatory authorities as well as the US Food and Drug Administration (FDA) for potential marketing approval.
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-dependant cellular cytotoxicity (ADCC). As a result, GA101’s clinical development program is designed to show superiority to MabThera/Rituxan in CLL and non-Hodgkin lymphoma (NHL).

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