GA 101 success in Phase III study for treatment of Chronic Lymphocytic Leukemia

The first results are announced by Genentech from CLL11, a Phase III study of the investigational medicine GA 101 (obinutuzumab) which is being conducted in collaboration with the German CLL Study Group (GCLLSG). The CLL11 study compared the combination of either GA 101 or Rituxan (rituximab) and chlorambucil, a standard chemotherapy, to chlorambucil alone in Chronic Lymphocytic Leukemia.

GA 101 combined with chlorambucil demonstrated a significant 86 percent reduction in the risk of disease progression, relapse or death. Additionally, the length of time during which people lived without their disease worsening (median progression-free survival, PFS) was more than doubled (23 months compared to 10.9 months, HR=0.14, 95 percent CI 0.09-0.21, p<.0001) when compared to chlorambucil alone. the full data including the comparison of rituxan plus chlorambucil with chlorambucil alone will be presented in an oral session at the 49th annual meeting of the asco in chicago on tuesday june 4.>

Based on the CLL11 data, marketing applications have been submitted to regulatory authorities including the European Medicines Association (EMA) and the FDA.