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Relapse with chemorefractory disease is common in patients with acute myeloid leukemia (AML) and is a major cause of therapy failure and death.1 Maintenance approaches with low-toxicity regimens to delay or prevent relapse after consolidation is an emerging area.1 One promising combination is low-dose azacitidine (Aza) + venetoclax (Ven).
Recently, Bazinet et al.1 published results from a phase II trial (NCT04062266) evaluating the safety and efficacy of low-dose Aza + Ven as maintenance therapy in patients with AML remission after either intensive or low-intensity induction in The Lancet Haematology. We summarize the key results below.
Table 1. Survival endpoints for patients with AML remission after intensive or low-intensity induction and treated with low-dose Aza + Ven*
Survival endpoint |
Cohort 1 (n = 25) |
Cohort 2 (n = 10) |
---|---|---|
Median RFS, months |
Not reached |
30.3 |
2-year RFS rate, % |
71 |
52 |
Median modified RFS, months† |
Not reached |
23.5 |
2-year modified RFS rate, % |
64 |
34 |
Median DOR, months |
Not reached |
30.3 |
2-year DOR rate, % |
71 |
52 |
Median OS, months |
Not reached |
Not reached |
2-year OS rate, % |
77 |
60 |
Median EFS, months |
Not reached |
23.5 |
2-year EFS rate, % |
59 |
34 |
Aza, azacitidine; AML, acute myeloid leukemia; DOR, duration of remission; EFS, event-free survival; OS, overall survival; RFS, relapse-free survival; Ven, venetoclax. |
Key learnings |
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