Demographic and disease characteristics at baseline
| . | R/R AML . | All patients (N = 345) . | |
|---|---|---|---|
| Enasidenib, 100 mg/d (n = 214) . | All doses (n = 280) . | ||
| Age, median (range), y | 68 (19-100) | 68 (19-100) | 69 (19-100) |
| Age ≥75 y, n (%) | 51 (24) | 66 (24) | 94 (27) |
| Sex, n (%) | |||
| Male | 109 (51) | 153 (55) | 201 (58) |
| Female | 105 (49) | 127 (45) | 144 (42) |
| WHO 2008 AML classification, n (%) | N = 319 | ||
| Myelodysplasia-related changes | 46 (22) | 63 (23) | 77 (24) |
| Recurrent genetic abnormalities | 28 (13) | 36 (13) | 38 (12) |
| Therapy-related myeloid neoplasms | 5 (2) | 6 (2) | 8 (3) |
| Not otherwise specified | 115 (54) | 144 (51) | 164 (51) |
| Missing* | 20 (9) | 31 (11) | 32 (10) |
| No. of prior cancer regimens, n (%) | N = 302 | ||
| 1 | 101 (47) | 125 (45) | 136 (45) |
| 2 | 65 (30) | 82 (29) | 88 (29) |
| ≥3 | 48 (22) | 73 (26) | 78 (26) |
| Time from initial diagnosis, median (range), mo | 10.4 (1.2-129) | 10.6 (1.2-129) | 8.6 (0.1-356) |
| R/R AML with prior history of MDS, n (%) | N/A | ||
| Yes | 46 (21) | 58 (21) | — |
| No | 168 (79) | 222 (79) | — |
| Outcomes of prior AML therapy, n (%)†,‡ | N/A | ||
| Refractory to initial induction or reinduction treatment | 64 (33) | 85 (33) | — |
| R/R to ≥2 cycles of first-line nonintensive therapy | 57 (29) | 75 (29) | — |
| Relapsed within 1 y of initial treatment | 55 (28) | 71 (28) | — |
| Relapsed posttransplant | 29 (15) | 41 (16) | — |
| In second or later relapse | 27 (14) | 36 (14) | — |
| Relapsed >1 y after initial treatment | 13 (6) | 20 (7) | — |
| Cytogenetic risk status, n (%) | |||
| Intermediate risk | 108 (50) | 141 (50) | 173 (50) |
| Poor risk | 55 (26) | 69 (25) | 84 (24) |
| Missing | 51 (24) | 70 (25) | 88 (26) |
| Prior stem cell transplantation, n (%) | 29 (14) | 41 (15) | 45 (13) |
| ECOG performance status, n (%) | |||
| 0 | 49 (23) | 62 (22) | 79 (23) |
| 1 | 132 (62) | 170 (61) | 204 (59) |
| 2 | 32 (15) | 47 (17) | 61 (18) |
| Missing | 1 (<1) | 1 (<1) | 1 (<1) |
| IDH2 mutant allele, n (%) | |||
| R140 | 162 (76) | 209 (75) | 259 (75) |
| R172 | 51 (24) | 70 (25) | 84 (24) |
| Other/missing | 1 (<1) | 1 (<1) | 2 (1) |
| Bone marrow blasts percentage, median (range)§ | 46.5 (0-98) | 46.0 (0-98) | 42.0 (0-98) |
| Hematology, median (range) | |||
| White blood cells, 109/L | 2.3 (0.2-94) | 2.3 (0.2-94) | 2.4 (0.2-94) |
| Hemoglobin, g/dL | 9.0 (6.9-15.6) | 9.1 (6.9-15.6) | 9.0 (6.9-15.6) |
| Platelets, 109/L | 37 (1-1288) | 40 (1-1288) | 42.9 (1-1288) |
| Baseline transfusion dependence, n (%) | |||
| RBC | 153 (71) | 202 (72) | 250 (72) |
| Platelets | 132 (62) | 165 (59) | 195 (57) |
| . | R/R AML . | All patients (N = 345) . | |
|---|---|---|---|
| Enasidenib, 100 mg/d (n = 214) . | All doses (n = 280) . | ||
| Age, median (range), y | 68 (19-100) | 68 (19-100) | 69 (19-100) |
| Age ≥75 y, n (%) | 51 (24) | 66 (24) | 94 (27) |
| Sex, n (%) | |||
| Male | 109 (51) | 153 (55) | 201 (58) |
| Female | 105 (49) | 127 (45) | 144 (42) |
| WHO 2008 AML classification, n (%) | N = 319 | ||
| Myelodysplasia-related changes | 46 (22) | 63 (23) | 77 (24) |
| Recurrent genetic abnormalities | 28 (13) | 36 (13) | 38 (12) |
| Therapy-related myeloid neoplasms | 5 (2) | 6 (2) | 8 (3) |
| Not otherwise specified | 115 (54) | 144 (51) | 164 (51) |
| Missing* | 20 (9) | 31 (11) | 32 (10) |
| No. of prior cancer regimens, n (%) | N = 302 | ||
| 1 | 101 (47) | 125 (45) | 136 (45) |
| 2 | 65 (30) | 82 (29) | 88 (29) |
| ≥3 | 48 (22) | 73 (26) | 78 (26) |
| Time from initial diagnosis, median (range), mo | 10.4 (1.2-129) | 10.6 (1.2-129) | 8.6 (0.1-356) |
| R/R AML with prior history of MDS, n (%) | N/A | ||
| Yes | 46 (21) | 58 (21) | — |
| No | 168 (79) | 222 (79) | — |
| Outcomes of prior AML therapy, n (%)†,‡ | N/A | ||
| Refractory to initial induction or reinduction treatment | 64 (33) | 85 (33) | — |
| R/R to ≥2 cycles of first-line nonintensive therapy | 57 (29) | 75 (29) | — |
| Relapsed within 1 y of initial treatment | 55 (28) | 71 (28) | — |
| Relapsed posttransplant | 29 (15) | 41 (16) | — |
| In second or later relapse | 27 (14) | 36 (14) | — |
| Relapsed >1 y after initial treatment | 13 (6) | 20 (7) | — |
| Cytogenetic risk status, n (%) | |||
| Intermediate risk | 108 (50) | 141 (50) | 173 (50) |
| Poor risk | 55 (26) | 69 (25) | 84 (24) |
| Missing | 51 (24) | 70 (25) | 88 (26) |
| Prior stem cell transplantation, n (%) | 29 (14) | 41 (15) | 45 (13) |
| ECOG performance status, n (%) | |||
| 0 | 49 (23) | 62 (22) | 79 (23) |
| 1 | 132 (62) | 170 (61) | 204 (59) |
| 2 | 32 (15) | 47 (17) | 61 (18) |
| Missing | 1 (<1) | 1 (<1) | 1 (<1) |
| IDH2 mutant allele, n (%) | |||
| R140 | 162 (76) | 209 (75) | 259 (75) |
| R172 | 51 (24) | 70 (25) | 84 (24) |
| Other/missing | 1 (<1) | 1 (<1) | 2 (1) |
| Bone marrow blasts percentage, median (range)§ | 46.5 (0-98) | 46.0 (0-98) | 42.0 (0-98) |
| Hematology, median (range) | |||
| White blood cells, 109/L | 2.3 (0.2-94) | 2.3 (0.2-94) | 2.4 (0.2-94) |
| Hemoglobin, g/dL | 9.0 (6.9-15.6) | 9.1 (6.9-15.6) | 9.0 (6.9-15.6) |
| Platelets, 109/L | 37 (1-1288) | 40 (1-1288) | 42.9 (1-1288) |
| Baseline transfusion dependence, n (%) | |||
| RBC | 153 (71) | 202 (72) | 250 (72) |
| Platelets | 132 (62) | 165 (59) | 195 (57) |
During the study, the protocol was amended to determine AML subtypes according to the WHO classification scheme (AML classification was previously determined by French–American–British criteria).
Prior AML treatment of R/R AML patients only.
Individual patients may be counted in >1 category.
Local assessment.
ECOG, Eastern Cooperative Oncology Group; N/A, not applicable; WHO, World Health Organization.