Table 1.
Demographics
| Characteristic∗ | Overall N = 50 |
Arm A: AZA + ENA n = 27 |
Arm B: ENA n = 23 |
|---|---|---|---|
| Age, median (range) | 73 (46-83) | 73 (49-83) | 73 (46-82) |
| Gender, n (%) | |||
| Female | 19 (38) | 12 (44) | 7 (30) |
| Male | 31 (62) | 15 (56) | 16 (70) |
| Subtype, n (%) | |||
| RAEB-T (AML-MRC) | 3 (6.0) | 1 (3.7) | 2 (8.7) |
| CMML | 5 (10) | 2 (7.4) | 3 (13) |
| MDS-EB1 | 10 (20) | 7 (26) | 3 (13) |
| MDS-EB2 | 17 (34) | 10 (37) | 7 (30) |
| MDS-MLD | 12 (24) | 4 (15) | 8 (35) |
| MDS/MPN-U | 1 (2.0) | 1 (3.7) | — |
| MPN/MDS | 2 (4.0) | 2 (7.4) | — |
| R-IPSS, n (%) | |||
| Intermediate | 14 (28) | 6 (22) | 8 (35) |
| Low | 6 (12) | 3 (11) | 3 (13) |
| High | 19 (38) | 12 (44) | 7 (30) |
| Very high | 11 (22) | 6 (22) | 5 (22) |
| Cytogenetic risk, n (%) | |||
| Good | 23 (46) | 13 (48) | 10 (43) |
| Intermediate | 17 (34%) | 8 (30) | 9 (39) |
| Poor | 8 (16) | 5 (19) | 3 (13) |
| Very good | 2 (4.0) | 1 (3.7) | 1 (4.3) |
| IDH2 isoform, n (%) | |||
| R140 | 47 (94) | 25 (93) | 22 (96) |
| R172 | 3 (6.0) | 2 (7.4) | 1 (4.3) |
| IDH2 variant n (%) | |||
| R140L | 2 (4.0) | 1 (3.7) | 1 (4.3) |
| R140Q | 43 (86) | 23 (85) | 20 (87) |
| R140W | 2 (4.0) | 1 (3.7) | 1 (4.3) |
| R172K | 3 (6.0) | 2 (7.4) | 1 (4.3) |
| Transfusion dependent, n (%) | 15 (30) | 4 (15) | 11 (48) |
| RBC dependent | 11 (22) | 2 (7.4) | 9 (39) |
| Platelet dependent | 1 (2.0) | 1 (3.7) | — |
| RBC and platelet dependent | 3 (6.0) | 1 (3.7) | 2 (8.7) |
| Number of prior therapies, median (range) | — | — | 1 (1-4) |
| Cycles of HMA received, median (range) | — | — | 8 (6-36) |
| Baseline hematologic parameters, median (range) | |||
| Absolute neutrophil count | 0.80 (0.01-21.41) | 0.78 (0.01-21.41) | 1.24 (0.10-6.35) |
| Hemoglobin | 9.10 (7.40-14.00) | 9.60 (7.40-14.00) | 8.60 (7.60-11.80) |
| Platelet | 117 (3-436) | 116 (19-368) | 123 (3-436) |
AZA, azacytidine; AML-MRC, AML with myelodysplasia related changes; CMML, chronic myelomonocytic leukemia; EB, excess blast; ENA, enasidenib; RAEB-T, refractory anemia with excess blasts in transformation; RBC, red blood cell; R-IPSS, revised international prognostic scoring system.
∗
Values are presented as median (range) or number (%).