Roche has announced that its Phase III VIALE-A study, evaluating Venclexta/Venclyxto (venetoclax) in combination with azacitidine for acute myeloid leukaemia (AML), has met its dual primary endpoints.

Aiming to improve both overall survival and composite complete remission rate, the first-in-class targeted medicine and hypomethylating agent combo showed a statistically significant improvement in overall survival in people with previously untreated versions of the disease.

The pharma giant also reported that safety for Venclexta/Venclyxto with azacitidine appeared consistent with the known safety profile of these medicines.

Further and more detailed data will be shared with global health authorities and presented at an upcoming medical meeting.

“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/Venclyxto-based combination can bring to patients and we look forward to discussing the results with health authorities.”

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.

AML is an aggressive form of leukaemia that starts in immature forms of blood-forming cells, known as myeloid cells, found in the bone marrow. It is the most common type of aggressive leukaemia in adults, and has the lowest survival rate of all types of leukaemia.