AbbVie said combining Venclexta (ingredient: venetoclax), a treatment for chronic lymphocytic leukemia, with chemotherapy drug azacitidine, helped prolong overall survival in patients with acute myeloid leukemia (AML) who did not have any previous treatment.
The company announced the results of the phase-3 VIALE-A trial, which compared the efficacy of the combination of Venclexta and azacitidine with that of azacitidine and placebo in 433 patients.
The study met two primary endpoints – a statistically significant improvement of overall survival (OS), and composite complete remission rate (CR + CRi), according to AbbVie.
An independent data monitoring committee recommended that the company should submit the study results to the U.S. Food and Drug Administration and global regulatory authorities early, the company said.
The results will be presented at a medical meeting or published in a peer-reviewed journal shortly, it added.
AML is one of the most aggressive and hard-to-treat blood cancers with a significantly low survival rate at 1.2 percent.
The five-year survival rate for patients with AML is around 28 percent.
In the U.S. in November 2018, the company obtained accelerated approval for Venclexta in combination with azacitidine, decitabine, or low-dose cytarabine for newly-diagnosed AML adult patients aged 75 or more.
AbbVie also received the nod for Venclexta in Mexico, Israel, Puerto Rico, Peru, Brazil, Russia, Argentina, Guatemala, Uruguay, Lebanon, Bahrain, Kazakhstan, Panama, Saudi Arabia, Taiwan, Australia, Qatar, and United Arab Emirates.
“For the past three decades, there have been few options for patients with AML who cannot receive or tolerate intensive chemotherapy or a bone marrow transplant," said Neil Gallagher, chief medical officer and vice president of development at AbbVie, in a statement.
“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 and reflect our ongoing commitment to transform the standards of care for patients with hematologic malignancies.”
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