Gazyva Wallops Rituxan in CLL Trial

Genentech/Roche has posted new data from the second stage of its Phase III CLL11 study. This study conducted in cooperation with the German CLL Study Group, compared Gazyva (obinutuzumab) in combination with chlorambucil to Rituxan (rituximab) in combination with chlorambucil for people with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions. The data showed that people treated in the Gazyva arm lived nearly a year longer without their disease worsening (progression-free survival, or PFS).

For patients in the Gazyva arm, median PFS was 26.7 months compared with 15.2 months for those in the Rituxan arm. Additional data comparing the Gazyva and Rituxan treatment arms showed higher complete response rates (21% compared with 7%) and a tenfold increase in the percentage of people achieving minimal residual disease (MRD) negativity (29.4% compared with 2.5%), which was defined as no detectable disease in the blood at the end of the treatment course.

An updated analysis from the first stage (Stage 1a) of the CLL11 study, which compared Gazyva in combination with chlorambucil to chlorambucil alone, showed that people treated with Gazyva in combination with chlorambucil lived longer (overall survival, or OS) compared to chlorambucil alone. Given the median observation time of 23 months, median overall survival has not yet been reached in any of the study arms.