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Adding the BCL-2 inhibitor venetoclax to azacitidine more than doubled remission rates and extended median survival from 9.6 to 14.7 months in unfit AML patients.
VIALE-A randomised 431 patients with newly diagnosed AML who were ineligible for intensive induction (median age 76) in a 2:1 ratio to azacitidine plus venetoclax or azacitidine plus placebo. Primary endpoints were overall survival and composite complete remission. Median OS was 14.7 versus 9.6 months (hazard ratio 0.66); complete remission was 36.7% versus 17.9% and complete remission with incomplete count recovery 66.4% versus 28.3%, with responses achieved faster and more often MRD-negative. Febrile neutropenia (42% versus 19%) and infections were more frequent with venetoclax. The regimen became the global standard for unfit AML.
VIALE-A turned a palliative regimen into one that produces remission in two-thirds of older AML patients and is now the reference treatment for anyone not fit for intensive chemotherapy. It shifted the field towards lower-intensity targeted combinations and opened the door to adding FLT3, IDH and menin inhibitors to the backbone. Cure remains uncommon and most patients relapse within two years.
Shares Courtney D. DiNardo, AGILE: ivosidenib plus azacitidine for newly diagnosed IDH1-mutated AML in patients unfit for intensive chemotherapy, Acute myeloid leukaemia in older or unfit patients, Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome.
Shares Secondary and therapy-related acute myeloid leukaemia, Acute myeloid leukaemia in older or unfit patients, Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome, Azacitidine.
Shares Venetoclax + hypomethylating agent, Shorter venetoclax courses in unfit AML, Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome, Venetoclax.
Shares Menin inhibitor + venetoclax + azacitidine, MRD-negative complete remission, Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome, MD Anderson Cancer Center.
Shares BCL-2, AbbVie (incl. ImmunoGen, Capstan), Overall survival (OS), Venetoclax.
Shares Acute myeloid leukaemia in older or unfit patients, Azacitidine, Venetoclax, Acute myeloid leukaemia.
Shares Shorter venetoclax courses in unfit AML, Acute myeloid leukaemia in older or unfit patients, Azacitidine.
Shares Acute myeloid leukaemia in older or unfit patients, Azacitidine, New England Journal of Medicine, Acute myeloid leukaemia.