AbbVie's Venclexta + azacitidine combo meets endpoints in previously-untreated AML

23 March 2020

US biopharma AbbVie (NYSE: ABBV) today announced that the Phase III VIALE-A trial of (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, the trial results will be reported early, and the data from the trial will be submitted to the US Food and Drug Administration and global health authorities. Venclexta generated sales of $792 million for AbbVie in 2019, up some 100% on the previous year.

Just last month, the VIALE-C (M16-043) trial of Venclexta in combination with low-dose cytarabine (LDAC) versus LDAC in combination with placebo failed to meet its primary endpoint of statistically-significant improvement of overall survival (OS) for patients with AML who are ineligible for intensive chemotherapy at the time of the planned analysis.

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