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The phase III VIALE-A trial (NCT02993523) is a randomized, double-blind study investigating the use of venetoclax + azacitidine (Ven+Aza) for the treatment of patients with newly diagnosed acute myeloid leukemia (AML). This study has previously been reported on the AML Hub and demonstrated that patients treated with Ven+Aza had higher rates of composite complete remission (CRc; complete remission [CR] + CR with incomplete hematologic recovery) and measurable residual disease response (MRD <10−3) compared with those treated with azacitidine alone (23.4% vs 7.6%; p < 0.001).
As there is limited evidence of the clinical significance of MRD monitoring in patients receiving low-intensity chemotherapy, Keith Pratz and colleagues investigated the prognostic impact of MRD <10−3 on the outcome of patients from the VIALE-A study who were treated with Ven+Aza. The results of this study were presented during the European Hematology Association (EHA)2021 Virtual Congress and are summarized below.
Table 1. Baseline patient characteristics*
*Data from Pratz et al.1 |
||
Characteristic, n |
CRc + MRD <10−3 |
CRc + MRD ≥10−3 |
---|---|---|
Age group, years |
|
|
18 to <65 |
2 |
1 |
65 to <75 |
27 |
26 |
≥75 |
38 |
70 |
Gender, male/female |
34/33 |
64/36 |
ECOG performance score |
|
|
0–1 |
38 |
63 |
2–3 |
29 |
34 |
Cytogenetic risk |
|
|
Intermediate |
51 |
65 |
Poor |
16 |
32 |
Type of AML |
|
|
De novo AML |
49 |
71 |
Secondary AML |
18 |
26 |
Molecular mutations |
|
|
FLT3 ITD/TKD |
10 |
10 |
IDH1/2 |
21 |
22 |
TP53 |
6 |
14 |
NPM1 |
15 |
2 |
Table 2. Responses*
*Data from Pratz et al.1 CI, confidence interval; CRc, composite complete response; DoR, duration of response; EFS, event free survival; MRD, minimal residual disease; NR, not reached; OS, overall survival. |
||||
Response |
18-month estimate, % (95% CI) |
Median response, months (95% CI) |
||
---|---|---|---|---|
CRc + MRD <10−3 |
CRc + MRD ≥10−3 |
CRc + MRD <10−3 |
CRc + MRD ≥10−3 |
|
DoR |
69.6 (55.9–79.8) |
33.5 (22.9–44.5) |
NR (19.3–NR) |
9.7 (8.0–15.8) |
EFS |
73.7 (61.1–82.8) |
33.9 (24.4–43.6) |
NR (19.7–NR) |
10.6 (9.0–13.9) |
OS |
84.6 (73.3–91.4) |
50.1 (39.6–59.8) |
NR (24.4–NR) |
18.7 (12.9–NR) |
Figure 1. Adverse events*
*Adapted from Pratz et al.1
AE, adverse event; CRc, composite complete response; MRD, minimal residual disease.
Patients with newly diagnosed AML treated with Ven+Aza who achieved CRc and an MRD response <10−3 had a longer DoR, EFS, and OS compared with those who did not achieve an MRD response (≥10−3). Higher rates of neutropenia were observed in patients that achieved an MRD response compared with those who did not. MRD response was also a significant predictor of OS, however, further studies are required to investigate the role of MRD response in clinical management.
References
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