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ASH 2022: Final Results of the VIALE-A Trial Assessing Venetoclax Plus Azacitidine
Posted: Dec 11, 2022
ASH 2022: Final Results of the VIALE-A Trial Assessing Venetoclax Plus Azacitidine   image

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.

A total of 431 untreated AML patients ineligible for intensive chemotherapy

ARM: Venetoclax + Azacitidine

ARM: Placebo + Azacitidine

286 patients

145 patients

Oral 400 mg Venetoclax daily, 28-day cycles

Oral Placebo daily, 28-day cycles

Azacitidine was administered to all patients at the standard dose: 75 mg/m2 subcutaneously or intravenously on days 1 through 7 every 28-day cycle

 

Molecular Abnormalities

Patients with Venetoclax+Azacitidine

FLT3

14.1%

IDH1/2

24.9%

TP53

23.3%

NPM1

16.6%

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:

Group Type

Groups 

Patients

Median Overall Survival (OS)

All Patients (Figure 1)

Venetoclax and Azacitidine

286

14.7 months 

(12.1 - 18.7)

Placebo and Azacitidine

145

9.6 months 

(7.4 - 12.7)

Patients that achieved CR+CRi and MRD negative 10-3

Venetoclax and Azacitidine

69 of 286

34.2 months 

(27.7 - 44)

Placebo and Azacitidine

11 of 145

25 months

(7 - 39.8)

Patients that achieved CR+CRi and MRD positive 10-3

Venetoclax and Azacitidine

96 of 286

18.7 months

(12.9 - 23.5)

Placebo and Azacitidine

24 of 145

15.1 months 

(7.4 - 26.1)

Patients in the IDH1/2 mutant subgroup (Figure 2)

Venetoclax and Azacitidine

61 of 286

19.9 months

(12.2 - 27.7)

Placebo and Azacitidine

28 of 145

6.2 months

(2.3 - 12.7)

 

 

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 

Side Effect

Grade

Groups 

Patients affected

Nausea

Any

Venetoclax and Azacitidine

44.5%

Placebo and Azacitidine

36.8%

Diarrhea

Any

Venetoclax and Azacitidine

45.2%

Placebo and Azacitidine

34%

Constipation

Any

Venetoclax and Azacitidine

43.8%

Placebo and Azacitidine

18.8%

Low Platelets

≥ 3

Venetoclax and Azacitidine

45.9%

Placebo and Azacitidine

39.6%

Low Neutrophils

≥ 3

Venetoclax and Azacitidine

42.8%

Placebo and Azacitidine

28.5%

Fever due to Low Neutrophils

≥ 3

Venetoclax and Azacitidine

42.8%

Placebo and Azacitidine

18.8%

Any serious adverse event

Venetoclax and Azacitidine

85.1%

Placebo and Azacitidine

77.1%

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.

The author Arturo Hurtado

about the author
Arturo Hurtado

Arturo Hurtado is an International Medical Graduate who joined HealthTree in 2020 as part of the Patient Experience team. He helps patients understand their disease panorama and navigate their AML through the tools and resources that HealthTree provides. He is an enthusiastic photographer, tech nerd, and aspiring food explorer who loves to travel and find new exciting experiences.

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