THE HAGUE, Netherlands, June 13, 2020 /PRNewswire/ -- Acute myeloid leukemia (AML) is primarily a disease of older adults. Standard commonly utilized lower-intensity therapies, such as azacitidine or decitabine, provide only limited responses with expected median survival of 9-10 months and complete remission (CR) / CR with incomplete count recovery (CRi) rates <40%. We evaluated the efficacy of a combination regimen of azacitidine and venetoclax in treatment-naïve AML patients that were ineligible for intensive therapy.
In a Phase III randomized double-blinded multicenter trial called "VIALE-A", the efficacy of the combination regimen was compared to treatment with azacytidine plus a placebo. In 431 internationally enrolled patients in the VIALE-A trial, the combination of azacitidine and venetoclax led to improved overall survival (14.7 vs 9.6 months), and improved response rates CR/CRi (66% vs 28%), compared to azacitidine alone. In addition, the combination was associated with responses that occurred more quickly (median time to CR/CRi was only 1.3 months) and were more durable (lasting 1.5 years), and with increased incidence of transfusion independence (58% vs 34%).
In conclusion, this practice-changing multicenter randomized Phase III trial establishes venetoclax and azacitidine as a new standard of care for older patients with AML.
Presenter: Dr Courtney D. DiNardo
Affiliation: MD Anderson Cancer Center, Houston, Texas, USA
Abstract: #LB2601 VIALE-A: A Randomized, Double-blind, Placebo-Controlled Study of Venetoclax with Azacitidine vs Azacitidine in Treatment-naïve Patients with Acute Myeloid Leukemia Ineligible for Intensive Chemotherapy
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