Venetoclax regimen extends OS in treatment-naive acute myeloid leukemia
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The addition of venetoclax to azacitidine extended OS for patients with previously untreated acute myeloid leukemia, according to topline results of a randomized phase 3 trial released by the agent’s manufacturer.
The combination also appeared associated with a higher composite complete remission rate.
Venetoclax (Venclexta; AbbVie, Genentech) selectively binds and inhibits the BCL-2 protein.
The double-blind, placebo-controlled VIALE-A study included 431 patients with previously untreated AML who were ineligible for intensive chemotherapy.
Researchers assigned two-thirds of patients to venetoclax dosed at 400 mg daily plus azacitidine. The other patients received placebo plus azacitidine.
OS and rate of complete remission or complete remission with incomplete blood count recovery served as primary endpoints. EFS, rate of complete remission or complete remission with partial hematologic recovery, transfusion independence and patient-reported outcomes served as secondary endpoints.
The study met both primary endpoints. The venetoclax-azacitidine combination exhibited a safety profile consistent with the known profiles of each agent.
Complete results of the study will be submitted for presentation at a medical meeting.
“Acute myeloid leukemia remains a challenging blood cancer, with particularly low median survival rates in patients who cannot tolerate intensive chemotherapy given their age or underlying health,” Levi Garraway, MD, PhD, chief medical officer and head of global product development for Roche, said in a company-issued press release. “These data validate the benefit that this [venetoclax]-based combination can bring to patients, and we look forward to discussing the results with health authorities.”
The FDA previously approved venetoclax as part of combination treatment for patients with newly diagnosed AML who are aged 75 years or older, as well as for those ineligible for intensive induction chemotherapy due to coexisting medical conditions.