AbbVie Announces New Undetectable Minimal Residual Disease Data from Phase 3 Relapsed/Refractory Chronic Lymphocytic Leukemia MURANO Trial of Venetoclax in Combination with Rituximab at 23rd European Hematology Association Annual Congress
NORTH CHICAGO, Ill., June 15, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today 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 test2) 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.1 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. 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.3 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.2 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.4 "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." Design and Results of the Phase 3 Study Summary of EHA Presentation A high PB/BM MRD concordance was seen with VenR in patients with paired samples (84 percent). Achievement of uMRD was independent of risk factors, including del(17p), IgVH mutation and TP53 mutations. Eighty-three percent of VenR patients who attained uMRD at EOCT maintained this status and were progression-free for a median of 13.8 months (range, 5.6-23.0 months) after EOCT.1 About VENCLYXTO® (venetoclax) VENCLYXTO 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. Together, the companies are committed to BCL-2 research with venetoclax, which is currently being evaluated in Phase 3 clinical trials for the treatment of relapsed/refractory CLL, along with studies in several other cancers. Venetoclax is currently approved in the European Union, Switzerland, Argentina, Australia, Mexico, Puerto Rico, Israel, USA, and Canada. AbbVie, in collaboration with Roche and Genentech, is currently working with regulatory agencies around the world to bring this medicine to eligible patients in need. For more information on B-cell lymphoma-2 (BCL-2), please read "Bringing Death to Cancer Cells" on www.abbvie.com. Important VENCLYXTO (venetoclax) EU Safety Information Contraindications Special Warnings & Precautions for Use Neutropenia (grade 3 or 4) has been reported and complete blood counts should be monitored throughout the treatment period. Live vaccines should not be administered during treatment or thereafter until B-cell recovery. Drug Interactions Avoid concomitant use of P-gp and BCRP inhibitors at initiation and during the dose titration phase. Avoid coadministration with strong or moderate CYP3A inducers. These agents may decrease venetoclax plasma concentrations. Co-administration of bile acid sequestrants with VENCLYXTO is not recommended as this may reduce the absorption of VENCLYXTO. Adverse Reactions The most frequently occurring adverse reactions (>=2%) were pneumonia, febrile neutropenia and TLS. Discontinuations due to adverse reactions occurred in 9.1% of patients and dosage adjustments due to adverse reactions occurred in 11.8% of patients. Specific Populations VENCLYXTO may cause embryo-fetal harm when administered to a pregnant woman. Advise females of reproductive potential to avoid pregnancy during treatment. Advise nursing women to discontinue breastfeeding during treatment. This is not a complete summary of all safety information. See VENCLYXTO full summary of product characteristics (SmPC) at www.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information. About AbbVie AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2017 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 1 Hillmen P, et al. High, durable minimal residual disease negativity with venetoclax + rituximab in relapsed/refractory chronic lymphocytic leukemia: minimal residual disease kinetics and responses in cytogenetic risk groups in patients from the Phase 3 MURANO Study. Presented at the 2018 European Hematology Association Congress; June 16, 2018; Stockholm.
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