Phase 3 Study for Acute Myeloid Leukemia Treatment Shows Positive Results


The phase 3 trial showed a statistically significant improvement in overall survival (OS) and composite complete remission rate.

The phase 3 VIALE-A study of venetoclax (Venclexta, AbbVie) in combination with azacitidine (Vidaza) in patients with acute myeloid leukemia (AML) showed a statistically significant improvement in overall survival (OS) and composite complete remission rate.

AML is an aggressive and difficult to treat blood cancer with a very low survival rate. Despite advancing research and treatments, the 5-year survival rate for patients diagnosed with AML remains approximately 28%. The disease typically progresses quickly and is the most common acute leukemia globally. An estimated 160,000 people have the disease globally, with an incidence rate of 103 new cases per 100,000 people.

Venetoclax may represent a new treatment option, according to the study findings. The drug is a first-in-class medication that selectively binds and inhibits the B-cell lymphoma 2 (BCL-2) protein, which prevents cancer cells from undergoing their natural death or self-destruction process in some blood cancers.

It can cause serious adverse effects (AEs), including tumor lysis syndrome, neutropenia, and infections. The most common AEs of venetoclax include low white blood cell counts, low platelet counts, low red blood cell counts, diarrhea, nausea, upper respiratory tract infection, cough, and muscle and joint pain.

The VIALE-A trial enrolled 443 treatment-naive patients with AML, 433 of whom were randomized in the double-blind, placebo-controlled phase 3 trial. The study met its dual primary endpoints of OS and composite complete remission.

AbbVie received accelerated approval in the United States for venetoclax in combination with azacytidine, decitabine, or low-dose cytarabine for the treatment of newly-diagnosed AML in adults 75 years of age or older, or who have comorbidities that preclude use of intensive induction chemotherapy.


AbbVie Announces Positive Topline Results from Phase 3 Trial of Venclexta (venetoclax) in Combination with Azacitidine in Patients with Acute Myeloid Leukemia (AML) [news release]. AbbVie; March 23, 2020. Accessed March 23, 2020.

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