Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new, positive data from the second stage of the CLL11 study. This Phase III study, conducted in cooperation with the German CLL Study Group, compared Gazyva™ (obinutuzumab), also known as GA101, 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 (HR 0.39, CI 0.31-0.49, p<0.0001). No new safety signals were observed for either Gazyva or Rituxan. The data have been accepted for presentation during the Plenary Scientific Session of the 55th Annual Meeting of American Society of Hematology (Abstract #6).
“Gazyva is the result of years of research for patients with chronic lymphocytic leukemia,” said Hal Barron, M.D., chief medical officer and head of Global Product Development. “These new data are important because they showed for the first time that Gazyva significantly extended progression-free survival when directly compared against Rituxan.”
Additional data comparing the Gazyva and Rituxan treatment arms showed higher complete response rates (21 percent compared with 7 percent) and a ten-fold increase in the percentage of people achieving minimal residual disease (MRD) negativity (29.4 percent compared with 2.5 percent), which was defined as no detectable disease in the blood at the end of the treatment course.
In addition to the Stage 2 data being presented at ASH, an updated analysis from the first stage (Stage 1a) of the CLL11 study, which compared Gazyva in combination with chlorambucil to chlorambucil alone, will also be presented. This analysis showed that people treated with Gazyva in combination with chlorambucil lived longer (overall survival, or OS) compared to chlorambucil alone (HR 0.41, 95 percent CI 0.23-0.74, p=0.002). Given the median observation time of 23 months, median overall survival has not yet been reached in any of the study arms.