AbbVie and Roche have announced the publication of results from the phase 3 VIALE-A trial of Venclyxto in patients with acute myeloid leukaemia (AML) in the New England Journal of Medicine.
The study evaluated newly-diagnosed AML patients who had not yet been treated and couldn’t tolerate traditional invasive chemotherapy. Researchers found that Venclyxto (venetoclax) – known as Venclexta in the US – in combination with azacitidine extended overall survival (OS) compared to the azacitidine plus placebo arm.
The median OS for patients receiving the Venclyxto combination treatment was 14.7 months versus 9.6 months in the placebo arm, with the treatment also reducing the risk of death by 34% compared to azacitidine plus placebo.
In addition, 66.4% of patients treated with the Venclyxto treatment regimen achieved composite complete remission versus 28.3% of patients treated in the placebo group.
The safety profile of the treatment was found to be generally consistent with the known safety profiles of Venclyxto combined with azacitidine.
The most common adverse events were mostly haematology and gastrointestinal in nature, with the most frequent serious adverse reactions being febrile neutropenia and pneumonia.
“The ability of Venclyxto plus azacitidine to improve outcomes of newly-diagnosed AML patients unable to tolerate intensive chemotherapy represents a potentially practice-changing advance in AML treatment,” said Courtney DiNardo, Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center and the lead study investigator.
In March, the European Commission approved Venclyxto in combination with Gazyvaro (obinutuzumab) as a chemotherapy-free therapy for previously-untreated chronic lymphocytic leukaemia (CLL).
The approval in CLL was based on the CLL14 trial, in which the combination led to a 5% reduction in the risk of disease progression or death compared with Gazyvaro plus chlorambucil in the first-line treatment setting.
Venclyxto is an important growth driver for AbbVie and Roche, with sales of the drug more than doubling last year to $792m, and sales are expected to top $1.3bn in 2020. AbbVie sells the drug on its own outside the US, while Roche’s Genentech division shares commercialisation in the US market.