AbbVie’s New Undetectable Minimal Residual Disease Data from Phase 3 MURANO Trial

AbbVie, a research-based global biopharmaceutical company, announced the presentation of investigational data from a new analysis of undetectable minimal residual disease (uMRD) rates from the pivotal Phase 3 MURANO trial of venetoclax, a first-in-class oral B-cell lymphoma-2 (BCL-2) inhibitor, in combination with rituximab (VenR) in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). Of the 121 patients who achieved uMRD (meaning less than one CLL cell in 10,000 white blood cells were detectable using a standardized test) at the end of combination therapy (EOCT), 83 percent (n=100) maintained uMRD and were progression-free for a median of 13.8 months (range, 5.6-23.0 months) thereafter. These results will be presented in an oral session on Saturday, June 16, at 11:45 a.m. CEST during the 23rd European Hematology Association (EHA) Annual Congress in Stockholm.  Venetoclax is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the US and by AbbVie outside of the US.

CLL is a slow-growing form of leukemia, or blood cancer, in which too many immature lymphocytes (type of white blood cells) are found predominantly in the blood and bone marrow. Undetectable minimal residual disease is an objective measure defined by the presence of less than one CLL cell in 10,000 white blood cells remaining in the blood or bone marrow following treatment. Prospective clinical trials have suggested that achieving undetectable minimal residual disease, also known as MRD negativity (MRD-), may have a prognostic impact on response duration and survival outcomes. “In this analysis of MRD data in patients with chronic lymphocytic leukemia given venetoclax in combination with rituximab, high and durable undetectable MRD rates were achieved in peripheral blood at the end of combination treatment assessment regardless of the risk features,” said Peter Hillmen, Ph.D., Professor of Experimental Hematology, Leeds Teaching Hospital in the UK, and lead investigator of the MURANO study. “These undetectable MRD results, along with data regarding the nearly 14-month progression-free findings in patients who maintained undetectable MRD, are an encouraging finding from the MURANO study.”

“The venetoclax data being presented at EHA adds to the growing body of evidence that supports a correlation between undetectable minimal residual disease (MRD) and improved clinical outcomes for patients with chronic lymphocytic leukemia,” said Neil Gallagher, M.D., Ph.D., Head of Global Oncology Development, AbbVie. “We continue to investigate the correlation between undetectable MRD and clinical outcomes following treatment with venetoclax alone, or in novel combinations, for the potential treatment of patients with chronic lymphocytic leukemia and other blood cancers.” – Medical Buyer Bureau