AbbVie, Roche’s Venclexta nails confirmatory combo trial in AML after flopping earlier study

Weeks after AbbVie and Roche’s blood cancer med Venclexta flopped a confirmatory trial in acute myeloid leukemia (AML), the partners hoped for a win to keep their med’s chances alive. Now, a Venclexta-chemo combo has hit its marks in a second trial, easing concerns the drug’s label will take a major hit. 

A combination of Venclexta and chemotherapy azacitidine beat out azacitidine alone at extending AML patients’ lives and rates of remission, according to top-line results from the phase 3 Viale-A trial released Monday. 

Data from the study will be reported early, per an independent data monitoring committee’s recommendation, and submitted to the FDA and global health authorities, AbbVie said in a release. The companies will unveil the details at a future medical meeting or in a peer-reviewed journal. 

RELATED: AbbVie, Roche’s Venclexta endangers AML approval with flopped confirmatory trial 

The Venclexta-azicitidine trial win comes within weeks of another Venclexta combo flopping a confirmatory trial in AML, where the drug received an accelerated FDA approval back in November 2018.