Positive Results from Phase III MURANO Trial Evaluating Venetoclax in Combination With Rituximab in Relapsed/Refractory CLL

The phase III MURANO study of venetoclax (Venclexta) tablets in combination with rituximab (Rituxan) met its primary endpoint. Results showed that the combination prolonged progression-free survival in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) compared with bendamustine combined with rituximab. An independent data monitoring committee reviewed this study and made the recommendation to unblind the trial based on the positive results. Doctors will continue to monitor patients who remain active in the MURANO trial in efforts to obtain additional, longer-term safety and efficacy information.

Venetoclax is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S., and by AbbVie outside of the U.S.

“AbbVie is committed to researching the full potential of [venetoclax] both as monotherapy and combination therapy in patients with CLL and other hematologic malignancies. The analysis of the MURANO trial showed that [venetoclax] in combination with [rituximab] may offer another option for patients with relapsed/refractory CLL, potentially providing them with a chemotherapy-free therapy," said Michael Severino, MD, Executive Vice President, Research and Development, and Chief Scientific Officer, AbbVie. “We are looking forward to working with regulatory authorities around the world to bring this additional treatment regimen to relapsed/refractory CLL patients.”

About the MURANO Study

The multicenter, open-label, randomized phase III MURANO study was designed to evaluate the efficacy and safety of venetoclax in combination with rituximab compared with bendamustine in combination with rituximab in patients with relapsed/refractory CLL. The primary endpoint was investigator-assessed progression-free survival, which was determined using standard International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines.

Secondary endpoints included Independent Review Committee (IRC)-assessed progression-free survival (as well as progression-free survival in patients with 17p deletion); best overall response (defined as complete response, complete response with incomplete marrow recovery, nodular partial remission, or partial remission); overall survival; event-free survival; duration of response; time to next anti-CLL treatment; and percentage of patients achieving minimal residual disease negativity.

Full data from this study will support regulatory submissions for venetoclax in combination with rituximab therapy in relapsed/refractory CLL, and will be presented at an upcoming medical conference.

Safety data, including serious and most common adverse events and discontinuation rates, are currently being analyzed.

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®.




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