AbbVie is developing venetoclax in alliance with Roche. Credit: AbbVie Inc.

AbbVie has reported positive results from the Phase III VIALE-A clinical trial of Venclexta (venetoclax) plus azacitidine in treatment-naïve acute myeloid leukaemia (AML) patients who cannot receive intensive chemotherapy.

Developed in alliance with Roche, Venclexta is designed to selectively attach to and block the B-cell lymphoma-2 (BCL-2) protein to restore apoptosis in certain blood cancers.

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The randomised, double-blind, placebo-controlled VIALE-A study compared the safety and efficacy of venetoclax combination to placebo plus azacytidine in a total of 443 patients.

Trial data showed that AbbVie’s drug combination met the dual primary endpoints of statistically significant improvement in overall survival (OS) and composite complete remission rate (CR + CRi).

The safety profile of the drug combination was observed to be generally consistent with that found in prior Phase I/II trials and known profiles of the individual medicines.

According to an independent data monitoring committee (IDMC) recommendation and prespecified interim analysis plan, the positive overall survival data at the first interim analysis will allow early reporting.

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The company also plans to submit the results to the US Food and Drug Administration (FDA).

AbbVie chief medical officer and development vice-president Neil Gallagher said: “For the past three decades, there has been few options for patients with AML who cannot receive or tolerate intensive chemotherapy or a bone marrow transplant.

“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.”

Venetoclax plus azacitidine, decitabine or low-dose cytarabine (LDAC) secured US Food and Drug Administration (FDA) approval in November 2018 to treat newly-diagnosed AML in adults aged 75 and above.

The combination holds approval in multiple other markets, including Australia, Mexico, and Israel.

The company performed VIALE-C as confirmatory trials in addition to VIALE-A.