Patient demographics and disease characteristics
| Characteristic . | Magrolimab, venetoclax, and azacitidine (n = 189) . | Placebo, venetoclax, and azacitidine (n = 189) . |
|---|---|---|
| Age, median (range), y | 75 (43-88) | 75 (28-91) |
| ≥75, n (%) | 96 (50.8) | 98 (51.9) |
| Male, n (%) | 116 (61.4) | 106 (56.1) |
| Race, n (%) | ||
| White | 130 (68.8) | 130 (68.8) |
| Asian | 26 (13.8) | 25 (13.2) |
| Black | 3 (1.6) | 2 (1.1) |
| Other | 4 (2.1) | 2 (1.1) |
| Not available | 26 (13.8) | 30 (15.9) |
| Geographic region, n (%) | ||
| United States | 46 (24.3) | 47 (24.9) |
| Ex-United States | 143 (75.7) | 142 (75.1) |
| 2017 ELN genetic risk group,∗ n (%) | ||
| Favorable/intermediate | 73 (38.6) | 88 (46.6) |
| Adverse | 84 (44.4) | 67 (35.4) |
| TP53 mutation,† n/N (%) | 37/124 (29.8) | 35/120 (29.2) |
| ECOG PS, n (%) | ||
| 0 | 35 (18.5) | 35 (18.5) |
| 1 | 83 (43.9) | 70 (37.0) |
| 2 | 66 (34.9) | 73 (38.6) |
| 3 | 5 (2.6) | 11 (5.8) |
| BM blast count, n (%) | ||
| <30% | 89 (47.1) | 87 (46.0) |
| ≥30% to <50% | 40 (21.2) | 38 (20.1) |
| ≥50% | 50 (26.5) | 51 (27.0) |
| Missing | 10 (5.3) | 13 (6.9) |
| Patients <75 y with ≥1 comorbidity, n (%) | 72 (38.1) | 75 (39.7) |
| ECOG PS score of 2 or 3 | 52 (27.5) | 62 (32.8) |
| Diffusing capacity of the lung ≤65% or FEV1 ≤65% | 18 (9.5) | 18 (9.5) |
| LVEF ≤50% | 8 (4.2) | 5 (2.6) |
| Total bilirubin >1.5× ULN | 4 (2.1) | 3 (1.6) |
| Other comorbidity‡ | 26 (13.8) | 27 (14.3) |
| Characteristic . | Magrolimab, venetoclax, and azacitidine (n = 189) . | Placebo, venetoclax, and azacitidine (n = 189) . |
|---|---|---|
| Age, median (range), y | 75 (43-88) | 75 (28-91) |
| ≥75, n (%) | 96 (50.8) | 98 (51.9) |
| Male, n (%) | 116 (61.4) | 106 (56.1) |
| Race, n (%) | ||
| White | 130 (68.8) | 130 (68.8) |
| Asian | 26 (13.8) | 25 (13.2) |
| Black | 3 (1.6) | 2 (1.1) |
| Other | 4 (2.1) | 2 (1.1) |
| Not available | 26 (13.8) | 30 (15.9) |
| Geographic region, n (%) | ||
| United States | 46 (24.3) | 47 (24.9) |
| Ex-United States | 143 (75.7) | 142 (75.1) |
| 2017 ELN genetic risk group,∗ n (%) | ||
| Favorable/intermediate | 73 (38.6) | 88 (46.6) |
| Adverse | 84 (44.4) | 67 (35.4) |
| TP53 mutation,† n/N (%) | 37/124 (29.8) | 35/120 (29.2) |
| ECOG PS, n (%) | ||
| 0 | 35 (18.5) | 35 (18.5) |
| 1 | 83 (43.9) | 70 (37.0) |
| 2 | 66 (34.9) | 73 (38.6) |
| 3 | 5 (2.6) | 11 (5.8) |
| BM blast count, n (%) | ||
| <30% | 89 (47.1) | 87 (46.0) |
| ≥30% to <50% | 40 (21.2) | 38 (20.1) |
| ≥50% | 50 (26.5) | 51 (27.0) |
| Missing | 10 (5.3) | 13 (6.9) |
| Patients <75 y with ≥1 comorbidity, n (%) | 72 (38.1) | 75 (39.7) |
| ECOG PS score of 2 or 3 | 52 (27.5) | 62 (32.8) |
| Diffusing capacity of the lung ≤65% or FEV1 ≤65% | 18 (9.5) | 18 (9.5) |
| LVEF ≤50% | 8 (4.2) | 5 (2.6) |
| Total bilirubin >1.5× ULN | 4 (2.1) | 3 (1.6) |
| Other comorbidity‡ | 26 (13.8) | 27 (14.3) |
FEV1, forced expiratory volume during the first second; LVEF, left ventricular ejection fraction; ULN, upper limit of normal.
Per electronic data capture using ELN 2017 criteria; 32 patients in the magrolimab arm and 34 in the control arm each had missing or unknown risk status.
Sixty-five patients in the magrolimab group and 69 in the control group had missing or unknown TP53 mutation status.
Any other comorbidity that the investigator judged to be incompatible with IC and was approved by the sponsor’s medical monitor before study enrollment.