On March 31, 2020 AbbVie (NYSE: ABBV ), a global research-based biopharmaceutical company, reported that the clinical trial VIALE-A (M15-656) of VENCLEXTA (venetoclax) in combination with azacitidine versus the azacitidine combination with placebo achieved its two main primary objectives: statistically significant improvement in overall survival and compound complete remission rate for patients with prior treatment AML and ineligible for treatment with intensive chemotherapy (Press release, AbbVie, MAR 31, 2020, View Source;842586695.html [SID1234556055]). The complete results will be submitted to the United States regulatory agency, FDA ( Food and Drug Administration ), and to global health authorities, and will also be presented at medical congresses or published in specialized journals.
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"In the past three decades, few options have emerged for AML patients who cannot receive or tolerate intensive chemotherapy or bone marrow transplantation," said physician Neil Gallagher , Ph.D., AbbVie medical director and vice president of development . "The positive results of the VIALE-A study support the clinical benefit of the combination venetoclax plus azacytidine in AML patients who are not eligible for intensive chemotherapy and reflect our ongoing commitment to transforming the standards of care for patients with hematological neoplasms."
AML is one of the most aggressive and difficult to treat blood cancers, with a very low survival rate 1,2 . Despite advances in available therapies and care, the 5-year survival rate for patients diagnosed with AML is approximately 28% 3 . AML generally worsens rapidly and, due to age and existing comorbidities, not all patients are eligible for intensive chemotherapy 4 . AML is the most common acute leukemia in the world 5 .
It is estimated that 160,000 people are currently living with the disease globally, with an incidence rate of 103 new cases per 100,000 people 5
The Phase 3 VIALE-A study evaluated the efficacy and safety of venetoclax in combination with azacitidine compared to the placebo plus azacitidine combination. The study achieved its two primary outcomes of overall survival and complete composite remission (CR + CRi). The observed safety profile is generally consistent with the known safety profile of venetoclax with azacytidine, as seen in previous Phase 1/2 studies and the known safety profiles of the two drugs.
In November 2018, AbbVie received rapid US approval of VENCLEXTA in combination with azacytidine, decitabine or low-dose cytarabine for the treatment of newly diagnosed AML in adults aged 75 years or older, or with comorbidities that prevent the use of chemotherapy. intensive induction based on Phase 1/2 studies. Approval was also granted by regulatory authorities in Mexico, Israel , Puerto Rico, Peru , Brazil, Russia, Argentina , Guatemala , Uruguay, Lebanon, Bahrain , Kazakhstan, Panama, Saudi Arabia, Taiwan , Australia, Qatar and the United Arab Emirates.
VENCLEXTA is being developed by AbbVie and Roche. It is marketed jointly by AbbVie and Genentech, a member of the Roche Group , in the USA, and by AbbVie outside the USA.
About the VIALE-A Phase 3 Study (M15-656)
A total of 443 patients with AML without prior treatment were included in the study and 433 were randomized to the Phase 3 VIALE-A, double-blind, placebo-controlled study. The study was developed to assess the efficacy and safety of venetoclax in combination with azacitidine (n = 287) compared to placebo in combination with azacitidine (n = 146). 6
About VENCLEXTA (venetoclax)
VENCLEXTA (venetoclax) is the first drug in the class to selectively inhibit BCL-2. In some types of cancer, BCL-2 prevents cancer cells from going through the natural process of death or self-destruction, called apoptosis. VENCLEXTA targets the BCL-2 protein and, through its mechanism of action, helps to restore the apoptosis process.
VENCLEXTA is being developed by AbbVie and Roche. It is marketed jointly by AbbVie and Genentech, a member of the Roche Group , in the USA and by AbbVie outside the USA. Together, the companies are committed to BCL-2 research and clinical studies of venetoclax for the treatment of various types of blood and other cancers. VENCLEXTA is approved in more than 50 countries, including the United States and Brazil.
About AbbVie in Oncology
At AbbVie, we strive to discover and develop drugs that provide transformative improvement in cancer treatment, uniquely combining our deep knowledge in key areas of biology with advanced technologies, and by working together with our partners – scientists, clinical experts, peers from industry, patient support groups and patients. We remain focused on generating these transformative advances in the treatment of some of the most complex and aggressive types of cancer. AbbVie’s oncology portfolio consists of drugs already in use and new molecules being evaluated worldwide, through more than 300 clinical studies and more than 20 different types of tumors. For more information, visit www.abbvie.com/oncology.