The outcomes have been offered within the digital 25th European Hematology Association (EHA) Annual Congress and have been printed right now within the New England Journal of Medicine.
The addition of venetoclax, an inhibitor of the BCL-2, to azacitidine resulted in a median OS of 14.7 months in comparison with 9.6 months in patients receiving azacitidine alone. Additionally, 66.4% of patients receiving the mixture therapy achieved full remission, whereas azacitidine alone achieved a 28.3% full remission fee.
The responses to remedy have been each fast and sturdy: 43% of patients within the mixture therapy group exhibited a response to remedy throughout the first cycle, and the noticed median length of remission was 17.5 months.
Treating a subgroup of AML patients with out efficient therapeutic optionsAlthough there may be not but a dependable commonplace remedy routine for AML, many patients obtain chemotherapy and/or a stem cell transplant. However, not all patients are eligible for these therapies.
“A large portion of patients with AML, including those older than 75 or those who have medical comorbidities, cannot tolerate existing treatment strategies, and the patients with AML who are ineligible for intensive chemotherapy often experience poor prognoses,” mentioned Courtney D. DiNardo, M.D., lead investigator and affiliate professor of Leukemia. “We launched the VIALE-A trial to evaluate whether we could safely use a combination therapy to treat this critical patient population.”
In this multi-institution trial, 431 patients have been randomized in a 2:1 ratio to obtain both the mixture of venetoclax and azacitidine or azacitidine plus placebo. The main goal was to guage whether or not the mixture improved OS in comparison with azacitidine, with extra targets to look at the security of the mixture therapy.
Combination remedy reveals constructive security outcomesThese outcomes display that the mixture of venetoclax and azacitidine has a security profile just like that of each medicine individually. The most typical hostile occasions in each the experimental and placebo remedy teams have been hematologic and gastrointestinal. In normal, charges of hostile occasions have been constant between the 2 remedy teams, though a better frequency of neutropenia (42% vs. 29%) and febrile neutropenia (42% vs.19%) was noticed with the mixture therapy comparted to azacitidine and placebo.
“The primary adverse events seen with azacitidine and venetoclax are related to increased cytopenias, including neutropenia and neutropenia-related infections,” mentioned DiNardo. “Key management guidelines include dosing interruptions between cycles to allow for count recovery in the setting of a leukemia-free marrow, and the use of granulocyte colony-stimulating factor as an adjunct to improve neutrophil count once a patient is in remission.”
New analysis offers choices for patients This analysis is prone to be practice-changing for the remedy of some teams of patients with AML. Additional analysis is required to guage how new therapies, together with this combination therapy, can enhance outcomes for all patients with AML.
“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,” mentioned DiNardo. “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.”
This trial (NCT02993523) was supported by Abbvie and Genentech.
University of Texas M. D. Anderson Cancer Center
Combination therapy improves survival outcomes for patients with acute myeloid leukemia (2020, August 13)
retrieved 13 August 2020
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