Table 1.
Baseline demographic and disease characteristics and details of prior AML-directed therapies
| Characteristic | Enasidenib (n = 158) | CCR (n = 161) | Total (N = 319) |
|---|---|---|---|
| Age (yr), median (range) | 72 (60-85) | 71 (60-86) | 71 (60-86) |
| Age ≥80 y, n (%) | 17 (10.8) | 12 (7.5) | 29 (9.1) |
| Sex, n (%) | |||
| Male | 91 (57.6) | 96 (59.6) | 187 (58.6) |
| Female | 67 (42.4) | 65 (40.4) | 132 (41.4) |
| AML setting, n (%) | |||
| De novo | 106 (67.1) | 115 (71.4) | 221 (69.3) |
| Secondary | 52 (32.9) | 46 (28.6) | 98 (30.7) |
| Mo since AML diagnosis, median (range) | 14.0 (1-113) | 14.0 (1-124) | 14.0 (1-124) |
| WHO AML classification, n (%) | |||
| AML not otherwise specified | 78 (49.4) | 88 (54.7) | 166 (52.0) |
| AML with myelodysplasia-related changes | 41 (25.9) | 41 (25.5) | 82 (25.7) |
| AML with recurrent genetic abnormalities | 34 (21.5) | 27 (16.8) | 61 (19.1) |
| Therapy-related myeloid neoplasms | 4 (2.5) | 5 (3.1) | 9 (2.8) |
| Missing | 1 (0.6) | 0 | 1 (0.3) |
| IDH2 mutation type, n (%) | |||
| IDH2-R140 | 115 (72.8) | 114 (70.8) | 229 (71.8) |
| IDH2-R172 | 43 (27.2) | 45 (28.0) | 88 (27.6) |
| Missing | 0 | 2 (1.2) | 2 (0.6) |
| ECOG PS score, n (%) | |||
| 0 | 40 (25.3) | 28 (17.4) | 68 (21.3) |
| 1 | 91 (57.6) | 99 (61.5) | 190 (59.6) |
| 2 | 27 (17.1) | 33 (20.5) | 60 (18.8) |
| 3 | 0 | 1 (0.6) | 1 (0.3) |
| ELN risk status, n (%) | |||
| Favorable | 13 (8.2) | 10 (6.2) | 23 (7.2) |
| Intermediate | 25 (15.8) | 24 (14.9) | 49 (15.4) |
| Adverse | 96 (60.8) | 105 (65.2) | 201 (63.0) |
| NE | 24 (15.2) | 22 (13.7) | 46 (14.4) |
| BM blasts, %, median (range) | 44 (5-99) | 42 (5-100) | 44 (5-100) |
| Hematologic parameters, median (range) | |||
| ANC, 109/L | 0.37 (0.00-15.4) | 0.58 (0.00-18.4) | 0.41 (0.00-18.4) |
| Hemoglobin, g/L | 92 (57-137) | 91 (50-132) | 92 (50-137) |
| WBC, 109/L | 2.5 (0.2-107) | 2.8 (0.1-191) | 2.6 (0.1-191) |
| Platelets, 109/L | 37 (4-655) | 36 (6-685) | 37 (4-685) |
| Number of prior AML therapies, n (%) | |||
| 1∗ | 3 (1.9) | 4 (2.5) | 7 (2.2) |
| 2 | 125 (79.1) | 121 (75.2) | 246 (77.1) |
| 3 | 29 (18.4) | 32 (19.9) | 61 (19.1) |
| 4∗ | 1 (0.6) | 4 (2.5) | 5 (1.6) |
| Prior intensive chemotherapy, n (%) | 117 (74.1) | 117 (72.7) | 234 (73.4) |
| Prior stem cell transplant, n (%) | 14 (8.9) | 19 (11.8) | 33 (10.3) |
| Prior R/R status, n (%) | |||
| Primary refractory AML† | 65 (41.1) | 64 (39.8) | 129 (40.4) |
| 2 prior relapses | 12 (7.6) | 23 (14.3) | 35 (11.0) |
| Duration of first remission ≤1 y | 12 (7.6) | 22 (13.7) | 34 (10.7) |
ANC, absolute neutrophil count; BM, bone marrow; CCR, conventional care regimen; CR, complete remission; CRi, CR with incomplete hematologic recovery; CRp, CR with incomplete platelet recovery; ECOG PS, Eastern Cooperative Oncology Group performance status; ELN, European LeukemiaNet; IQR, interquartile range; NE, not evaluated; WBC, white blood cell; WHO, World Health Organization.
∗
Receipt of <2 or >3 prior AML therapies was a protocol violation.
†
Never attained CR, CRi, or CRp during prior AML-directed therapy.