Roche has recently announced that the phase III VIALE-A study met its dual primary endpoints of overall survival and composite complete remission rate (CR + CRi). Venclexta or Venclyxto (venetoclax) in combination with azacitidine, a hypomethylating agent, showed a statistically significant improvement in overall survival in people with previously untreated acute myeloid leukaemia (AML) who were ineligible for intensive induction chemotherapy, compared to azacitidine alone. Safety for Venclexta or Venclyxto plus azacitidine appeared consistent with the known safety profile of these medicines.
“Acute myeloid leukaemia remains a challenging blood cancer, with particularly low median survival rates in patients who cannot tolerate intensive chemotherapy given their age or underlying health,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “These data validate the benefit that this Venclexta or Venclyxto-based combination can bring to patients, and we look forward to discussing the results with health authorities.”
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 US Food and Drug Administration (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.
AbbVie and Roche are developing Venclexta or Venclyxto. It is jointly commercialied by AbbVie and Genentech, a member of the Roche Group, in the US, and commercialised by AbbVie outside of the US.