Roche announces Venclexta/Venclyxto combination improved overall survival in people with previously untreated acute myeloid leukaemia - Seite 2

Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the US, and commercialised by AbbVie outside of the US.

About the VIALE-A study
VIALE-A (NCT02993523) is a phase III, randomised, double-blind, placebo-controlled multicentre study evaluating the efficacy and safety of Venclexta/Venclyxto plus azacitidine, a hypomethylating agent, compared to placebo plus azacitidine, in 431 people with previously untreated acute myeloid leukaemia who are ineligible for intensive chemotherapy. Two-thirds of patients received 400 mg Venclexta/Venclyxto daily, in combination with azacitidine, and the remaining patients received placebo tablets in combination with azacitidine. The primary endpoints of the study are overall survival, and rate of complete remission (CR) and CR with incomplete blood count recovery (CRi). Secondary endpoints include event free survival, CR and CR with partial haematologic recovery (CRh), transfusion independence and patient-reported outcomes.

About acute myeloid leukaemia
Acute myeloid leukaemia (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.¹ AML is the most common type of aggressive leukaemia in adults.[2] It has the lowest survival rate of all types of leukaemia.² Even with the best available therapies, older patients aged 65 and over have survival rates comparable to patients with advanced lung cancer, with a five year overall survival rate of <5%.^3,4 Approximately 20,000 people in the US and 18,000 in Europe are diagnosed with AML each year.[5,6]

About Venclexta/Venclyxto (venetoclax)
Venclexta/Venclyxto is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumours, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta/Venclyxto blocks the BCL-2 protein and works to restore the process of apoptosis.

Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the US, and commercialised by AbbVie outside of the US. Together, the companies are committed to research with Venclexta/Venclyxto, which is currently being studied in clinical trials across several types of blood and other cancers.