First-line treatment with a combination of Venclexta (venetoclax) and Vidaza (azacitidine) significantly extended survival in people with acute myeloid leukemia (AML) who were ineligible for intensive chemotherapy, as compared with Vidaza alone, AbbVie announced.
Venclexta works by blocking molecular pathways that cancer cells use to avoid death, thus sensitizing the cells to other cancer-killing agents.
This oral therapy, developed and marketed by AbbVie and Genentech, was given accelerated approved by the U.S. Food and Drug Administration (FDA) in 2018 to treat newly diagnosed AML patients who aren’t eligible for standard chemotherapy, either because they have particular health conditions or because they are over 75 years old. In these individuals, Venclexta is used in combination with Vidaza, Dacogen (decitabine), or cytarabine.
This approval was based on promising results from earlier clinical trials (NCT02287233 and NCT02203773). Under an accelerated approval, confirmatory trials are typically necessary to secure regulatory permission for the medicine’s continued use.
Results from one such Phase 3 clinical trial, VIALE-C (NCT03069352), showed no significant survival benefit after one year of treatment with Venclexta plus low-dose cytarabine, compared with cytarabine alone. However, its results indicated that combination therapy with Venclexta had clinical activity for some AML patients.
In the Phase 3 clinical trial VIALE-A (NCT02993523) — another confirmatory trial — 433 people newly diagnosed with AML who had not yet received treatment were randomized to either the Venclexta and Vidaza combination, or to Vidaza plus a placebo.
An interim analysis of results in this ongoing trial was positive. In accordance with a predetermined plan, and at the recommendation of an independent data monitoring committee, a decision was made to report the trial results early.
According to an Abbvie press release, the Venclexta combination significantly increased the overall survival rate compared with Vidaza alone. This combination also significantly increased rates of complete remission — the percentage of patients who were cleared of all detectable signs of cancer. Details were not released.
Full results will be shared at future medical meetings and/or published in peer-reviewed scientific journals, the company said.
“The positive results from VIALE-A support the clinical benefit of the venetoclax plus azacitidine combination in patients with AML who are ineligible for intensive chemotherapy,” said Neil Gallagher, MD, PhD, chief medical officer and vice president of development, AbbVie.
In addition to the U.S., Venclexta is approved to treat AML in countries that include Mexico, Israel, Brazil, Russia, Argentina, Saudi Arabia, Taiwan, and Australia. It is not currently approved for use by AML patients in Europe.