Table 1.
Baseline characteristics of patients.
| Venetoclax + Azacitidine | Azacitidine | |||
|---|---|---|---|---|
| FLT3 mutated | FLT3 wild type | FLT3 mutated | FLT3 wild type | |
| (n = 42)a | (n = 238) | (n = 22) | (n = 95) | |
| Age, median (range) | 75.0 (49.0–91.0) | 77.0 (53.0–90.0) | 75.0 (65.0–85.0) | 76.0 (60.0–90.0) |
| Age category - n (%) | ||||
| <65 | 3 (7.1) | 7 (2.9) | 0 | 4 (4.2) |
| 65–<75 | 17 (40.5) | 75 (31.5) | 9 (40.9) | 30 (31.6) |
| ≥75 | 22 (52.4) | 156 (65.5) | 13 (59.1) | 61 (64.2) |
| Gender - n (%) | ||||
| Female | 18 (42.9) | 97 (40.8) | 6 (27.3) | 39 (41.1) |
| Male | 24 (57.1) | 141 (59.2) | 16 (72.7) | 56 (58.9) |
| ECOG performance status - n (%) | ||||
| 0–1 | 17 (40.5) | 148 (62.2) | 11 (50.0) | 59 (62.1) |
| 2–3 | 25 (59.5) | 90 (37.8) | 11 (50.0) | 36 (37.9) |
| Cytogenetics - n (%) | ||||
| Intermediate | 36 (85.7) | 141 (59.2) | 21 (95.5) | 48 (50.5) |
| Poor | 6 (14.3) | 97 (40.8) | 1 (4.5) | 47 (49.5) |
| Bone marrow blast count - n (%) | ||||
| <30% | 7 (16.7) | 76 (31.9) | 3 (13.6) | 28 (29.5) |
| ≥30%–<50% | 4 (9.5) | 59 (24.8) | 4 (18.2) | 23 (24.2) |
| ≥50% | 31 (73.8) | 103 (43.3) | 15 (68.2) | 44 (46.3) |
| Type of AML - n (%) | ||||
| De novo AML | 33 (78.6) | 175 (73.5) | 19 (86.4) | 67 (70.5) |
| Secondary AML | 9 (21.4) | 63 (26.5) | 3 (13.6) | 28 (29.5) |
| AML-MRC - n (%) | 8 (19.0) | 81 (34.0) | 7 (31.8) | 36 (37.9) |
| RBC or platelet transfusion within 8 weeks prior to the first dose of study drug or randomization - n (%) | 24 (57.1) | 132 (55.5) | 17 (77.3) | 53 (55.8) |
| FLT3-ITD AR - n (%) | ||||
| <0.5 | 21 (70.0) | — | 8 (61.5) | — |
| ≥0.5 | 9 (30.0) | — | 5 (38.5) | — |
| Molecular mutations | ||||
| IDH1 or IDH2b | 10 (23.8) | 64 (27.6) | 2 (10.0) | 22 (23.4) |
| NPM1c | 15 (35.7) | 30 (12.6) | 8 (36.4) | 11 (11.6) |
Abbreviations: AML-MRC, AML with myelodysplasia-related changes; ECOG, Eastern Cooperative Oncology Group.
a FLT3 was detected by CDx assay in 40 patients and by MyAML assay in 2 patients. FLT3-ITD was detected by CDx assay in 28 patients and by MyAML assay in 2 patients.
b IDH1 or IDH2 was detected by CDx assay.
cNPM1 was detected by MyAML assay.