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Drug Combo Prolongs Survival in Acute Myeloid Leukemia

THURSDAY, Aug. 13, 2020 -- Overall survival is longer and the incidence of remission is higher among previously untreated, older patients with acute myeloid leukemia (AML) who receive azacitidine plus venetoclax versus azacitidine alone, according to a study published in the Aug. 13 issue of the New England Journal of Medicine to coincide with the virtual edition of the 25th European Hematology Association Annual Congress.

Courtney D. DiNardo, M.D., from the University of Texas MD Anderson Cancer Center in Houston, and colleagues randomly assigned 431 previously untreated patients with confirmed AML who were ineligible for standard induction therapy to a standard dose of azacitidine plus either venetoclax (286 participants) or matching placebo (145 participants).

The researchers found that at a median follow-up of 20.5 months, median overall survival was 14.7 months in the azacitidine-venetoclax group and 9.6 months in the control group (hazard ratio for death, 0.66). Further, in the azacitidine-venetoclax group, the incidence of complete remission was higher than that seen with the control regimen (36.7 versus 17.9 percent), as was the composite outcome of complete remission or complete remission with incomplete hematologic recovery (66.4 versus 28.3 percent). Common adverse events included nausea (44 percent in the azacitidine-venetoclax group and 35 percent in the control group), grade 3 or higher thrombocytopenia (45 and 38 percent, respectively), neutropenia (42 and 29 percent, respectively), and febrile neutropenia (42 and 19 percent, respectively). Infections of any grade were also common and occurred in 85 percent of patients in the azacitidine-venetoclax group and 67 percent in the control group. Serious adverse events occurred in 83 and 73 percent of participants, respectively.

"While this combination represents a key advance in AML therapy, improving both remission and survival rates in newly diagnosed patients with AML, many unfortunately will still relapse," DiNardo said in a statement. "Our next steps include an evaluation of azacitidine and venetoclax as a backbone to which additional novel therapeutics are being evaluated in particularly high-risk populations."

Several authors disclosed financial ties to pharmaceutical companies, including AbbVie and Genentech, which supported the study.

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