Baseline demographics and clinical characteristics
| Parameter . | Adult efficacy-evaluable population (n = 64) . | Safety population (N = 84) . |
|---|---|---|
| Age, median (range), y | 65 (19-84) | 63 (11-84) |
| <18, n (%) | 0 | 1 (1.2) |
| ≥18 to <65, n (%) | 31 (48.4) | 42 (50.0) |
| ≥65, n (%) | 33 (51.6) | 41 (48.8) |
| Sex, n (%) | ||
| Female | 38 (59.4) | 50 (59.5) |
| Male | 26 (40.6) | 34 (40.5) |
| Race, n (%) | ||
| Black or African American | 6 (9.4) | 7 (8.3) |
| Asian | 4 (6.3) | 5 (6.0) |
| White | 38 (59.4) | 48 (57.1) |
| Multiple | 1 (1.6) | 1 (1.2) |
| Other | 3 (4.7) | 3 (3.6) |
| Unknown | 9 (14.1) | 17 (20.2) |
| Missing | 3 (4.7) | 3 (3.6) |
| Disease status at baseline, n (%) | ||
| Primary refractory | 5 (7.8) | 7 (8.3) |
| Relapsed refractory | 35 (54.7) | 41 (48.8) |
| Early untreated relapse∗ | 17 (26.2) | 23 (27.4) |
| Late untreated relapse† | 7 (10.8) | 13 (15.5) |
| Extramedullary disease, n (%) | 4 (6.3) | 7 (8.3) |
| Co-occurring mutations, n (%) | ||
| FLT3-ITD | 22 (34.4) | 26 (31.0) |
| FLT3-TKD | 4 (6.3) | 6 (7.1) |
| RAS | 2 (3.1) | 3 (3.6) |
| TP53 | 4 (6.3) | 4 (4.8) |
| Previous therapies, n (%) | ||
| Median (range) | 2 (1-7) | 2 (1-7) |
| ≥3 | 23 (35.9) | 29 (34.5) |
| ≥4 | 14 (21.9) | 16 (19.0) |
| Venetoclax | 48 (75.0) | 62 (73.8) |
| HSCT | 14 (21.9) | 20 (23.8) |
| >1 previous HSCT | 4 (6.3) | 8 (9.5) |
| FLT3 inhibitor | 30 (46.9) | 32 (38.1) |
| IDH1 inhibitor | 3 (4.7) | 5 (6.0) |
| IDH2 inhibitor | 4 (6.3) | 5 (6.0) |
| Parameter . | Adult efficacy-evaluable population (n = 64) . | Safety population (N = 84) . |
|---|---|---|
| Age, median (range), y | 65 (19-84) | 63 (11-84) |
| <18, n (%) | 0 | 1 (1.2) |
| ≥18 to <65, n (%) | 31 (48.4) | 42 (50.0) |
| ≥65, n (%) | 33 (51.6) | 41 (48.8) |
| Sex, n (%) | ||
| Female | 38 (59.4) | 50 (59.5) |
| Male | 26 (40.6) | 34 (40.5) |
| Race, n (%) | ||
| Black or African American | 6 (9.4) | 7 (8.3) |
| Asian | 4 (6.3) | 5 (6.0) |
| White | 38 (59.4) | 48 (57.1) |
| Multiple | 1 (1.6) | 1 (1.2) |
| Other | 3 (4.7) | 3 (3.6) |
| Unknown | 9 (14.1) | 17 (20.2) |
| Missing | 3 (4.7) | 3 (3.6) |
| Disease status at baseline, n (%) | ||
| Primary refractory | 5 (7.8) | 7 (8.3) |
| Relapsed refractory | 35 (54.7) | 41 (48.8) |
| Early untreated relapse∗ | 17 (26.2) | 23 (27.4) |
| Late untreated relapse† | 7 (10.8) | 13 (15.5) |
| Extramedullary disease, n (%) | 4 (6.3) | 7 (8.3) |
| Co-occurring mutations, n (%) | ||
| FLT3-ITD | 22 (34.4) | 26 (31.0) |
| FLT3-TKD | 4 (6.3) | 6 (7.1) |
| RAS | 2 (3.1) | 3 (3.6) |
| TP53 | 4 (6.3) | 4 (4.8) |
| Previous therapies, n (%) | ||
| Median (range) | 2 (1-7) | 2 (1-7) |
| ≥3 | 23 (35.9) | 29 (34.5) |
| ≥4 | 14 (21.9) | 16 (19.0) |
| Venetoclax | 48 (75.0) | 62 (73.8) |
| HSCT | 14 (21.9) | 20 (23.8) |
| >1 previous HSCT | 4 (6.3) | 8 (9.5) |
| FLT3 inhibitor | 30 (46.9) | 32 (38.1) |
| IDH1 inhibitor | 3 (4.7) | 5 (6.0) |
| IDH2 inhibitor | 4 (6.3) | 5 (6.0) |