Roche announces positive phase III results for Venclexta/Venclyxto (venetoclax) plus azacytidine in AML

The phase III VIALE-A (NCT02993523) study evaluating the efficacy and safety of Venclexta®/Venclyxto® (venetoclax) plus azacytidine (a hypomethylating agent) in 433 patients with previously untreated acute myeloid leukaemia who were ineligible for intensive chemotherapy, has yielded positive results according to Roche. The combination was shown to reduce the risk of fatality by 34% versus placebo plus azacitidine in people with previously untreated AML, and also resulted in higher rates of composite complete remission at 66.4% versus 28.3% respectively. Safety for the combination was consistent with the known safety profile of these medicines and no unexpected safety signals were identified.

Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche said: “We are very pleased to present these important results from people with acute myeloid leukaemia, especially those who are unable to tolerate intensive chemotherapy and therefore have limited treatment options. The significant survival benefits observed in the VIALE-A study reinforce the potential utility of this Venclexta/Venclyxto-based combination for people with this aggressive disease.”