Data from the final analysis of the CLL11 study evaluating obinutuzumab (Gazyva)-based treatment in previously untreated chronic lymphocytic leukemia (CLL) was presented by Goede et al during the Presidential Symposium at the 23rd Annual Congress of the European Hematology Association (EHA) (Abstract S151).
After a follow-up of nearly 5 years, final results showed clinically meaningful improvements with obinutuzumab plus chlorambucil across multiple endpoints, including progression-free survival (PFS) and overall survival (OS), when compared head-to-head with rituximab (Rituxan) plus chlorambucil. Obinutuzumab-based treatment reduced the risk of death by 24% compared to rituximab-based treatment (median OS not reached vs 73.1 months, hazard ratio [HR] = 0.76; 95% confidence interval [CI] = 0.60–0.97; P < .0245). These new data add to the growing body of evidence for the OS benefit with obinutuzumab in first-line CLL after the previously reported OS benefit with obinutuzumab combined with chlorambucil vs chlorambucil alone.
After a median observation time of nearly 5 years (59.4 months) this final analysis of the CLL11 study demonstrated:
Obinutuzumab is currently approved in more than 90 countries in combination with chlorambucil for people with previously untreated CLL based on previously reported data from the CLL11 study.
About the CLL11 study
CLL11 is a phase III, multicenter, open-label, randomized three-arm study to investigate the safety and efficacy profile of obinutuzumab plus chlorambucil compared rituximab plus chlorambucil or chlorambucil alone in nearly 800 people with previously untreated CLL and comorbidities. The primary endpoint of the study is PFS with secondary endpoints including response rate, molecular remission rate, OS, TTNT, and safety profile. In terms of analysis, the study was divided into three stages:
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.