Venclexta + chemotherapy improved overall survival in VIALE-A study with patients with previously untreated acute myeloid leukemia. - Genentech /Roche

Genentech, a member of the Roche Group announced that the Phase III VIALE-A study met its dual primary endpoints of overall survival and composite complete remission rate (CR + CRi) . Venclexta (venetoclax) in combination with azacitidine, a hypomethylating agent, showed a statistically significant improvement in overall survival in people with previously untreated acute myeloid leukemia (AML) who were ineligible for intensive induction chemotherapy, compared to azacitidine alone. Safety for Venclexta plus azacitidine appeared consistent with the known safety profile of these medicines. Data from the VIALE-A study will be shared with global health authorities and presented at an upcoming medical meeting. Venclexta has previously been granted accelerated approval by the FDA in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of people with newly-diagnosed AML who are aged 75 years or older, or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions, based on response rates from the M14-358 and M14-387 studies. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory studies. Venclexta has also been granted five Breakthrough Therapy Designations by the FDA, including two for previously untreated AML. Comment: The earlier reported VIALE-C trial showed the Venclexta + cytarabine combination reduced the risk of death by 25%, which was a result that missed statistical significance. That finding raised questions similar trials could fail and shift the FDA to revoke its AML approval. This announcement of VIALE-A trial, however, should ease those concerns.