Roche announces Venclexta/Venclyxto combination improved overall survival in people with previously untreated AML
Roche announced that the phase III VIALE-A study met its dual primary endpoints of overall survival and composite complete remission rate (CR + CRi). Venclexta/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/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, M.D., Ph.D., 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.”
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.
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.
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.
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. AML is the most common type of aggressive leukaemia in adults. It has the lowest survival rate of all types of leukaemia. 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%. Approximately 20,000 people in the US and 18,000 in Europe are diagnosed with AML each year.
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.
In the US, Venclexta has been granted five Breakthrough Therapy Designations by the US Food and Drug Administration: one for previously untreated chronic lymphocytic leukaemia (CLL), two for relapsed or refractory CLL and two for previously untreated acute myeloid leukaemia.
“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, M.D., Ph.D., 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.”
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.
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.
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.
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. AML is the most common type of aggressive leukaemia in adults. It has the lowest survival rate of all types of leukaemia. 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%. Approximately 20,000 people in the US and 18,000 in Europe are diagnosed with AML each year.
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.
In the US, Venclexta has been granted five Breakthrough Therapy Designations by the US Food and Drug Administration: one for previously untreated chronic lymphocytic leukaemia (CLL), two for relapsed or refractory CLL and two for previously untreated acute myeloid leukaemia.
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