AbbVie has announced the VIALE-A (M15-656) trial of VENCLEXTA® (venetoclax) in combination with azacitidine versus azacitidine in combination with placebo met its dual primary endpoints of statistically significant improvement of overall survival (OS) and composite complete remission rate (CR + CRi) for patients with previously-untreated acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.
At the recommendation of an independent data monitoring committee, and per the prespecified interim analysis plan, due to positive efficacy results at the first interim analysis for overall survival, the trial results will be reported early, and the data from the trial will be submitted to the U.S. FDA and global health authorities. Results will be presented at a future medical meeting or published in a peer-reviewed journal.
AML is one of the most aggressive and difficult-to-treat blood cancers with a very low survival rate. Despite advances in available therapies and care, the 5-year survival rate for patients diagnosed with AML remains approximately 28%.
In November 2018, AbbVie received accelerated approval in the U.S. for VENCLEXTA in combination with azacitidine, decitabine, or low-dose cytarabine (LDAC) for the treatment of newly-diagnosed AML in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy based on the Phase 1/2 studies.