Table 1.
Patient demographics.
| Cohort | |||||
|---|---|---|---|---|---|
| Characteristic | Overall (N = 31) | DL1 (N = 6) | DL2 (N = 6) | DL3 (N = 13) | DL4 (N = 6) |
| Age, median (range) | 67 (44–84) | 69 (66–84) | 68 (44–80) | 65 (56–76) | 66 (56–76) |
| Gender, n/N (%) | |||||
| Female | 11/31 (35%) | 3/6 (50%) | 3/6 (50%) | 4/13 (31%) | 1/6 (17%) |
| Male | 20/31 (65%) | 3/6 (50%) | 3/6 (50%) | 9/13 (69%) | 5/6 (83%) |
| Bone marrow blast %, median (range) | 23 (1–80) | 31 (1–64) | 24 (10–61) | 35 (7–80) | 14 (6–32) |
| ECOG, n/N (%) | |||||
| 0 | 8/30 (27%) | 1/6 (17%) | 0/6 (0%) | 4/13 (31%) | 3/5 (60%) |
| 1 | 18/30 (60%) | 4/6 (67%) | 4/6 (67%) | 8/13 (62%) | 2/5 (40%) |
| 2 | 4/30 (13%) | 1/6 (17%) | 2/6 (33%) | 1/13 (7.7%) | 0/5 (0%) |
| Disease, n/N (%) | |||||
| MDS/MPN | 9/31 (29%) | 1/6 (17%) | 1/6 (17%) | 2/13 (15%) | 5/6 (83%) |
| t-MDS | 1/31 (3.2%) | 0/6 (0%) | 0/6 (0%) | 0/13 (0%) | 1/6 (17%) |
| R/R-MDS | 1/31 (3.2%) | 1/6 (17%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| ND-AML | 14/31 (45%) | 1/6 (17%) | 3/6 (50%) | 9/13 (69%) | 1/6 (17%) |
| De novo AML | 9/31 (29%) | 1/6 (17%) | 2/6 (33%) | 5/13 (38%) | 1/6 (17%) |
| ts-AML | 5/31 (16%) | 0/6 (0%) | 1/6 (17%) | 4/13 (31%) | 0/6 (0%) |
| R/R-AML | 8/31 (26%) | 4/6 (67%) | 2/6 (33%) | 2/13 (15%) | 0/6 (0%) |
| Prior treatment, n/N (%) | 15/31 (48%) | 5/6 (83%) | 3/6 (50%) | 6/13 (46%) | 1/6 (17%) |
| Lines of therapy n/N (%) | |||||
| 1 | 9/31 (29%) | 2/6 (33%) | 2/6 (33%) | 4/13 (31%) | 1/6 (17%) |
| 2 | 1/31 (3.2%) | 1/6 (17%) | 0/6 (0%) | 0/13 (0%) | 0/6 (0%) |
| 3 | 3/31 (9.7%) | 1/6 (17%) | 0/6 (0%) | 2/13 (15%) | 0/6 (0%) |
| 4 | 2/31 (6.5%) | 1/6 (17%) | 1/6 (17%) | 0/13 (0%) | 0/6 (0%) |
| Prior IDH inhibitor, n/N (%) | 3/31 (9.7%) | 2/6 (33%) | 1/6 (17%) | 0/13 (0%) | 0/6 (0%) |
| 2022 ELN risk group, n/N (%) | N = 22 | N = 5 | N = 5 | N = 11 | N = 1 |
| Favorable | 8/22 (36%) | 3/5 (60%) | 2/5 (40%) | 2/11 (18%) | 1/1 (100%) |
| Intermediate | 3/22 (14%) | 1/5 (20%) | 1/5 (20%) | 1/11 (9.1%) | 0/1 (0%) |
| Adverse | 11/22 (50%) | 1/5 (20%) | 2/5 (40%) | 8/11 (73%) | 0/1 (0%) |
Abbreviations: MDS, myelodysplastic syndrome; MPN, myeloproliferative neoplasm; ELN, European LeukemiaNet; R/R, relapsed/refractory; ND, newly diagnosed; ts-AML, treated-secondary AML; ECOG, Eastern Cooperative Oncology Group; t-MDS: therapy-related MDS.