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The combination of venetoclax (Ven) + azacitidine (Aza) was approved in 2018 for the treatment of patients with newly diagnosed acute myeloid leukemia, aged ≥75 years old, or ineligible for intensive chemotherapy. The phase III VIALE-A trial (NCT02993523) evaluating Ven + Aza vs placebo + Aza met its primary endpoint of improved overall survival (OS).
Recently, Pratz et al.1 published a long-term efficacy and safety follow-up of the VIALE-A trial in American Journal of Hematology. We summarize the key results below.
Figure 1. Median OS in the overall patient population and patient subgroups in the VIALE-A trial*
Aza, azacitidine; OS, overall survival; Ven, venetoclax.
*Adapted from Pratz et al.1
†Ven + Aza (n = 61), placebo + Aza (n = 28).
‡Ven + Aza (n = 23), placebo + Aza (n = 11).
§Ven + Aza (n = 40), placebo + Aza (n = 18).
Table 1. Any-grade hematologic and GI TEAEs in ≥20% of patients*
TEAE (%) |
Ven + Aza |
Placebo + Aza |
---|---|---|
Hematologic AE |
||
Thrombocytopenia |
47 |
42 |
Febrile neutropenia |
43 |
19 |
Neutropenia |
43 |
29 |
Anemia |
31 |
23 |
Leukopenia |
21 |
14 |
GI AE |
||
Diarrhea |
45 |
34 |
Nausea |
45 |
37 |
Constipation |
44 |
40 |
Vomiting |
30 |
24 |
AE, adverse event; AZA, azacitidine; GI, gastrointestinal; TEAE, treatment-emergent adverse event; VEN, venetoclax. |
Key learnings |
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