Roche, the world’s largest biotech company, has released 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 MabThera/Rituxan (rituximab) in combination with chlorambucil for people with previously untreated chronic lymphocytic leukaemia (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 MabThera/Rituxan arm (HR 0.39, CI 0.31-0.49, p<0.0001). No new safety signals were observed for either Gazyva or MabThera/Rituxan.

The data is presented during the Plenary Scientific Session of the 55th Annual Meeting of American Society of Hematology.

“Gazyva is the result of years of research for patients with chronic lymphocytic leukemia,” said Hal Barron, MD, Roche’s 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 MabThera/Rituxan.”

Additional data comparing the Gazyva and MabThera/Rituxan treatment arms showed higher complete response rates (21% compared with 7%) and a ten-fold 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.

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% 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.

On 1 November 2013, Gazyva in combination with chlorambucil became the first medicine with Breakthrough Therapy Designation to receive US Food and Drug Administration (FDA) approval. Roche has also submitted Marketing Authorisation Applications to other regulatory authorities around the world, including the European Medicines Agency (EMA).

CLL11 is a phase III, multi-centre, open-label, randomised three-arm study investigating the efficacy and safety profile of Gazyva plus chlorambucil, MabThera/Rituxan plus chlorambucil and chlorambucil alone in 781 previously untreated people with CLL and co-existing medical conditions who are in need of therapy. Stage 1 (n=589) compared Gazyva plus chlorambucil to chlorambucil alone and MabThera/Rituxan plus chlorambucil to chlorambucil alone. Stage 2 (n=663) compared Gazyva plus chlorambucil directly with MabThera/Rituxan plus chlorambucil.
The primary endpoint of the study was PFS with secondary endpoints including overall response rate (ORR), overall survival (OS), disease free survival (DFS), minimal residual disease (MRD) and safety profile.

Gazyva is a new monoclonal antibody designed to attach to CD20, a protein found only on B cells. It attacks targeted cells both directly and together with the body's immune system. Gazyva was discovered by Roche Glycart AG, a wholly owned, independent research unit of Roche. In the U.S., Gazyva is part of a collaboration between Genentech and Biogen Idec.

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