Roche shows improved survival rates in new treatment for untreated acute myeloid leukaemia

pharmafile | March 24, 2020 | News story | Manufacturing and Production Cancer, Roche, acute myeloid leukamia 

Roche has announced that its clinical trials for Venclexta/Venclyzto combination with azacitidine have met its primary endpoints of overall survival as well as complete remissions rates for patients with untreated acute myeloid leukaemia (AML).

The Phase III VIALE-A study showed a overall improvement in patient survival specifically for people with previously untreated AML who were ineligible for intensive induction chemotherapy. The safety of the treatment was consistent with the safety profiles of the mediciines involved.

The data from the trial will be shared with global health authorities. Venclexta has already been used to treat AML in the past. It was previously given accelerated approval by the FDA to be used in combination with azacitidine or decitabine to treat newly diagnosed patients who were over 75 and ineligible for chemotherapy.

Dr Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development, commented on the results, and said: “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. 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.”

AML is an aggressive form of the disease that starts in cells found in bone marrow and has the lowest survival rate of all types of leukaemia. 20,000 people in the US and 18,000 in Europe are diagnosed with AML every year.

Conor Kavanagh

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