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New England Journal of Medicine Publishes Positive Phase 3 Data of Venetoclax Combination in Acute Myeloid Leukemia (AML) Patients

Published: 2020-08-12 21:45:00 ET

- Data from Phase 3 VIALE-A study showed venetoclax plus azacitidine reduced the risk of death by 34% compared to azacitidine plus placebo in newly-diagnosed patients with AML who are ineligible for chemotherapy

- AML is one of the most aggressive blood cancers, with a very low survival rate and few options for patients who are unable to undergo intensive chemotherapy, the current standard of care(1,2)

NORTH CHICAGO, Ill., Aug. 12, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the publication of results from the Phase 3 VIALE-A clinical study in patients with AML in the New England Journal of Medicine (NEJM). The study, which evaluated newly-diagnosed AML patients who had not yet been treated and were unable to tolerate traditional intensive chemotherapy, found that venetoclax in combination with azacitidine extended overall survival (OS) compared to azacitidine plus placebo. The manuscript titled, "Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia," was published in the August 13, 2020 issue of NEJM.3

"The ability of venetoclax plus azacitidine to improve outcomes of newly-diagnosed AML patients unable to tolerate intensive chemotherapy represents a potentially practice-changing advance in AML treatment," said Courtney D. DiNardo, M.D., MSCE, Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center and the lead study investigator.

In the VIALE-A study, OS was the sole primary study endpoint in the U.S. OS and composite complete remission rate (CR+CRi) were co-primary endpoints in China, Japan, the European Union (EU) and EU reference countries. CR+CRi is a composite score reflecting the complete remission (CR) and CR with incomplete hematologic recovery (CRi), which is an incomplete CR with blood counts not fully recovered.4,5 Treatment with venetoclax plus azacitidine reduced the risk of death by 34% compared to azacitidine in combination with placebo (Hazard Ratio [HR]=0.66 [95% CI: 0.52-0.85], p

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All statements made via social media sites sponsored or maintained by Enhanced Investments and its affiliates are for informational purposes only and do not constitute a comprehensive description of Enhanced Investments' investment advisory services.
Certain investments are not suitable for all investors. Before investing, consider your investment objectives and applicable fees. The rate of return on investments can vary widely over time, especially for long term investments. Investment losses are possible, including the potential loss of all amounts invested. Information provided by Enhanced Investments is for informational and general educational purposes only and is not investment or financial advice.