Completion of CLL11 study for GA 101 (Genentech) for treatment of CLL
Genentech announced positive results from the Phase III CLL11 study for Chronic Lymphocytic Leukemia (CLL). At a pre-planned interim analysis, an independent data monitoring committee determined that the study met its primary endpoint showing that GA101 (obinutuzumab) plus chlorambucil helped people live significantly longer without their disease worsening (progression-free survival; PFS) compared to Rituxan (rituximab) plus chlorambucil. The CLL11 study is being conducted in cooperation with the German CLL Study Group (GCLLSG). These final data were reached well ahead of the target completion date in 2014 as a result of the magnitude of difference seen between the two study arms. No new safety signals for GA101 or Rituxan were identified in this analysis, and adverse events were similar to those observed in the first stage of the study which was previously reported earlier this year.
These data will be submitted for consideration to the 55th Annual Meeting of the American Society of Hematology (ASH) in New Orleans, which is taking place December 7-10, 2013.