Roche's Genentech Announces New Results From Cll11 Study Show Gazyva Provided People With Previously Untreated Chronic Lymphocytic Leukemia A Treatment-Free Period Of Nearly Four Years at #ASH2015

Genentech, a member of the Roche Group

, announced today updated data from the pivotal CLL11 study confirming that Gazyva (obinutuzumab) plus chlorambucil reduced the risk of disease worsening or death by more than half compared to Rituxan® (rituximab) plus chlorambucil (progression-free survival, PFS; HR=0.46, median PFS 28.7 months versus 15.7 months; p<0.0001). New results to be presented at the American Society of Hematology (ASH) Annual Meeting from a secondary endpoint that measured time to next treatment (TTNT) showed that, after completing the set six-month Gazyva regimen, people remained treatment-free for nearly four years on average before needing the next treatment for their cancer (TTNT; 51.1 months, including the six-month initial treatment period). No unexpected safety signals were observed with Gazyva. "These updated CLL11 data confirmed that Gazyva helped people with previously untreated chronic lymphocytic leukemia live significantly longer without disease worsening or death compared to Rituxan," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "After a fixed course of therapy with Gazyva, people remained treatment-free for nearly four years on average. Time free from treatment is an important consideration for a disease like CLL, which occurs in older adults who frequently have other health issues. " In the GREEN safety study, data from a subgroup analysis showed there were no unexpected safety signals when Gazyva was combined with bendamustine. In addition, nearly 80 percent of people responded to treatment with Gazyva plus bendamustine (overall response rate, ORR), and a third of people (32.3 percent) achieved a complete response (CR). A substantial number of people were also minimal residual disease (MRD)-negative when measured in the bone marrow or blood (28 percent and 59 percent, respectively), which means no cancer can be detected using a specific test. ORR and MRD-negativity were secondary endpoints of the study. Gazyva in combination with chlorambucil is approved in the United States for use in people with previously untreated CLL and in the EU for use in people with previously untreated CLL who have co-existing medical conditions (comorbidities) making them unsuitable for an intensive therapy (full-dose fludarabine based therapy).