ASH 2022: Final Results of the VIALE-A Trial Assessing Venetoclax Plus Azacitidine

Venetoclax is a promising BCL-2 inhibitor currently used in combination with other therapies to treat AML. Venetoclax shuts down BCL-2 which is an anti-apoptotic protein, meaning it stops cells from dying. Leukemia cells make this protein, so shutting it down kills the cancer cells.

Due to the results of the phase 3 VIALE-A study published in 2020, venetoclax and azacitidine were approved by the FDA and can now be used together to treat newly diagnosed AML patients who can't get intensive chemotherapy. After two more years of follow-up, during which all 360 of the expected survival events were measured, AML expert, Dr. Pratz, discussed the study's final results at the 64th Annual Meeting of the American Society of Hematology (ASH 2022).

Methods and Patients Included in the Study

The median age was 76 years in both groups, 60% were men and 76% were Caucasians.

Study Results

After a median of 43.2 months of follow-up, 49 patients remained in the study: 28 in the venetoclax group and 1 in the placebo group. The results of the study showed a clear benefit for the combination of venetoclax and azacitidine over azacitidine alone.

The outcomes were as follows:

Figure 1. Overall survival. This graph shows a sustained benefit of using venetoclax and azacitidine after 43.2 months of follow-up.
Figure 2. Overall survival of the IDH/2 mutant group. This graph shows an even more significant sustained benefit of using venetoclax and azacitidine for patients that have an IDH1/2 mutation after 43.2 months of follow-up.

Side Effects 

Take Away Points

• The long-term follow-up of VIALE-A shows that venetoclax and azacitidine are better in terms of overall survival (14.7 months), than Placebo and Azacitidine (9.6 months) in all subgroups of AML patients who are not eligible for intensive chemotherapy.
• Those patients in the ventoclax group that were MRD negative 10^-3 who had achieved a complete response had an improved 34.2 months overall survival, and patients with IDH1/2 mutations treated had an improved overall survival of was 19.9 months. 
• The VIALE-A 2-year follow-up analysis confirms the long-term survival benefit for patients treated with venetoclax and azacitidine, with no new side effects.

For more information about this clinical trial, click here.

Did you know you can learn more about clinical trials in HealthTree? Visit our AML Clinical Trial Finder.

HOW WE CAN HELP

If you need assistance finding or joining clinical trials, please contact our Patient Navigator Support Team at 1-800-930-5159 or email support@healthtree.org.