AbbVie announced the VIALE-A (M15-656) trial of VENCLEXTA® (venetoclax) in combination with azacitidine versus azacitidine in combination with placebo met its dual primary endpoints of statistically significant improvement of overall survival (OS) and composite complete remission rate (CR + CRi) for patients with previously-untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. At the recommendation of an independent data monitoring committee (IDMC), and per the prespecified interim analysis plan, due to positive efficacy results at the first interim analysis for overall survival, the trial results will be reported early, and the data from the trial will be submitted to the U.S. FDA and global health authorities. Results will be presented at a future medical meeting or published in a peer-reviewed journal.

"For the past three decades, there has been few options for patients with AML who cannot receive or tolerate intensive chemotherapy or a bone marrow transplant," said Neil Gallagher, M.D., Ph.D., chief medical officer and vice president of development, AbbVie. "The positive results from VIALE-A support the clinical benefit of the venetoclax plus azacitidine combination in patients with AML who are ineligible for intensive chemotherapy and reflect our ongoing commitment to transform the standards of care for patients with hematologic malignancies."

AML is one of the most aggressive and difficult-to-treat blood cancers with a very low survival rate. Despite advances in available therapies and care, the 5-year survival rate for patients diagnosed with AML remains approximately 28%. AML typically worsens quickly, and due to age and comorbidities, not all patients are eligible to receive intensive chemotherapy. AML is the most common acute leukemia in the world. An estimated 160,000 people are currently living with the disease globally with an incidence rate of 103 new cases per 100,000 people.

The Phase 3 VIALE-A study evaluated the efficacy and safety of venetoclax in combination with azacitidine compared with placebo in combination with azacitidine. The study met its dual primary endpoints of OS and composite complete remission (CR + CRi). At the recommendation of an IDMC, and per the prespecified interim analysis plan, due to positive efficacy results at the first interim analysis for overall survival, the trial results will be reported early, and the data from the trial will be submitted to the U.S. FDA and global health authorities. The observed safety profile is generally consistent with the known safety profile of venetoclax combined with azacitidine as observed in previous Phase 1/2 studies and the known safety profiles of the two medications.

In November 2018, AbbVie received accelerated approval in the U.S. for VENCLEXTA in combination with azacitidine, decitabine, or low-dose cytarabine (LDAC) for the treatment of newly-diagnosed AML in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy based on the Phase 1/2 studies. Approval was also granted in Mexico, Israel, Puerto Rico, Peru, Brazil, Russia, Argentina, Guatemala, Uruguay, Lebanon, Bahrain, Kazakhstan, Panama, Saudi Arabia, Taiwan, China, Australia, Qatar, and United Arab Emirates.

The Phase 3 VIALE-A and VIALE-C (M16-043) studies were conducted as confirmatory trials following the accelerated U.S. FDA approval of venetoclax in AML in 2018. In February 2020, AbbVie provided an update on the Phase 3 VIALE-C study of venetoclax in combination with LDAC compared with LDAC in combination with placebo.

VENCLEXTA 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.

A total of 443 treatment-naïve AML patients were enrolled and 433 were randomized in the double-blind, placebo-controlled Phase 3 VIALE-A trial. The trial was designed to evaluate the efficacy and safety of venetoclax in combination with azacitidine (n=287) compared with placebo in combination with azacitidine (n=146).

VENCLEXTA® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLEXTA targets the BCL-2 protein and works to help restore the process of apoptosis.

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