Secondary endpoints (TP53WT ITT population)
| . | Idasa-C (n = 232) . | Placebo-C (n = 123) . | OR or HR (95% CI) . | p value (HR) . |
|---|---|---|---|---|
| ORR [CR, CRp, CRi], n (%) | 90 (38.8) | 27 (22.0) | 2.25 (1.36-3.72) | .0008 |
| CR, n (%)* | 47 (20.3) | 21 (17.1) | 1.23 (0.70-2.18) | .408 |
| CRp, n (%) | 23 (9.9) | 4 (3.3) | — | — |
| CRi, n (%) | 20 (8.6) | 2 (1.6) | — | — |
| Median EFS, wk† | 6.3 | 4.4 | 0.65 | .0005 |
| n = 28 | n = 10 | |||
| DOR, median (95% CI), mo‡ | 13.9 (6.4, 21.1) | 29.4 (8.2, NE) | — | — |
| . | Idasa-C (n = 232) . | Placebo-C (n = 123) . | OR or HR (95% CI) . | p value (HR) . |
|---|---|---|---|---|
| ORR [CR, CRp, CRi], n (%) | 90 (38.8) | 27 (22.0) | 2.25 (1.36-3.72) | .0008 |
| CR, n (%)* | 47 (20.3) | 21 (17.1) | 1.23 (0.70-2.18) | .408 |
| CRp, n (%) | 23 (9.9) | 4 (3.3) | — | — |
| CRi, n (%) | 20 (8.6) | 2 (1.6) | — | — |
| Median EFS, wk† | 6.3 | 4.4 | 0.65 | .0005 |
| n = 28 | n = 10 | |||
| DOR, median (95% CI), mo‡ | 13.9 (6.4, 21.1) | 29.4 (8.2, NE) | — | — |
EFS, event-free survival; NE, not estimable.
CR was defined at the end of induction according to ELN 2017 criteria: bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count ≥1000 per μL; platelets ≥100 000 per μL.
EFS was defined as the time from randomization to treatment failure (failure to achieve CR, set as the day of last assessment), relapse from CR, or death from any cause.
DOR was defined as the time from achieving CR until relapse from CR or death from any cause.