NEJM: Venetoclax Treatment of Acute Myeloid Leukemia (AML), Phase III Clinically Positive Results.

AbbVie announced today that the results of Phase III clinical trials (VIALE-A) published in the New England Journal of Medicine (NEJM) assessed the effectiveness and safety of veetoclax in the treatment of primary AML patients, and showed that venetoclax combined azacsides extended overall survival (OS) compared to placebo combined azacine.
in the multi-center VIALE-A study, OS is the only major research endpoint in the United States, while the composite complete remission rate (CR-CRi) is the main endpoint of research in China, Japan and the European Union.
CR-CRi is a comprehensive score that reflects CR for complete remission (CR) and incomplete recovery of the blood system (CRi).
results showed that Venetoclax combined azacion reduced the risk of death by 34% compared to placebo combined azacine (HR-0.66, 95% CI: 0.52-0.85, p .lt;0.001).
of patients in the
Venetoclax combined treatment group had a mid-OS of 14.7 months (95%CI: 11.9-18.7), while 9.6 months (95% CI:7.4-12.7) of patients in the placebo group.
addition, 66.4% (95%CI:60.6-71.9) of patients treated with Veetoclax combined azacosine achieved CR-CRi and received comfort Only 28.3% (95% CI:21.1-36.3) of patients treated with the drug combined with azacidin reached CR-CRi (p .lt;0.001).
observed in the VIALE-A trial were consistent with the known safety of veetoclax and azacinoside.
The most common adverse events (AEs) in patients treated with veetoclax combined azacosine were mainly hematological and gastrointestinal diseases: platelet reduction (46 per cent), nausea (44 per cent), constipation (43 per cent), neutral granulocytic reduction (42 per cent), fever-neutral granulocytic reduction (42 per cent) and diarrhoea (41 per cent).
reported tumor dissolution syndrome (TLS) in three patients in the Veetoclax group, but not in the placebo group.
all of these are short-lived biochemical changes that can be addressed by using uric acid excretion agents.
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