Baseline characteristics of AML patients in dose escalation, RP2D, and PIF/ER subgroup analyses
| Characteristic . | Dose escalation, N = 42 . | RP2D population, N = 50 . | RP2D PIF/ER, N = 30* . |
|---|---|---|---|
| Age, median (range), y | 64 (29, 84) | 64 (27, 82) | 59 (27, 74) |
| Sex, female, n (%) | 18 (42.9) | 19 (38.0) | 10 (33.3) |
| AML status at entry, n (%) | |||
| Primary refractory, ≥2 induction attempts | 15 (35.7) | 24 (48.0) | 24 (80.0) |
| Early relapse, CR duration ≤6 mo | 8 (19.0) | 6 (12.0) | 6 (20.0) |
| AML risk stratification, ELN 2017, n (%) | |||
| Adverse | 13 (31.0) | 26 (52.0) | 18 (60.0) |
| Intermediate | 8 (19.0) | 12 (24.0) | 7 (23.3) |
| Favorable | 10 (23.8) | 6 (12.0) | 5 (16.7) |
| Secondary AML, n (%) | 10/42 (23.8) | 16/50 (32.0) | 12/30 (40) |
| No. of prior lines of therapy, median (range) | 2 (0, 9) | 3 (1, 9) | 4 (1, 9) |
| Failed induction therapy, n (%) | |||
| Cytarabine-based induction chemotherapy | N/A | N/A | 21 (70) |
| Alternative induction therapy | N/A | N/A | 3 (10) |
| ER, <6 mo | |||
| n (%) | 4 (9.5) | 6 (12) | 6 (20) |
| Median duration of CR (range), mo | N/A | 1.6 (0.8-5.1) | 1.6 (0.8-5.1) |
| BM blasts at time of study enrollment, median (range), % | 40 (2-98) | 46 (5-94) | 41 (5-94) |
| Baseline WBC, median (range), ×109/L | 2 (0.4-29.7) | 1.95 (0.3-67) | 2.35 (0.4-16.2) |
| Characteristic . | Dose escalation, N = 42 . | RP2D population, N = 50 . | RP2D PIF/ER, N = 30* . |
|---|---|---|---|
| Age, median (range), y | 64 (29, 84) | 64 (27, 82) | 59 (27, 74) |
| Sex, female, n (%) | 18 (42.9) | 19 (38.0) | 10 (33.3) |
| AML status at entry, n (%) | |||
| Primary refractory, ≥2 induction attempts | 15 (35.7) | 24 (48.0) | 24 (80.0) |
| Early relapse, CR duration ≤6 mo | 8 (19.0) | 6 (12.0) | 6 (20.0) |
| AML risk stratification, ELN 2017, n (%) | |||
| Adverse | 13 (31.0) | 26 (52.0) | 18 (60.0) |
| Intermediate | 8 (19.0) | 12 (24.0) | 7 (23.3) |
| Favorable | 10 (23.8) | 6 (12.0) | 5 (16.7) |
| Secondary AML, n (%) | 10/42 (23.8) | 16/50 (32.0) | 12/30 (40) |
| No. of prior lines of therapy, median (range) | 2 (0, 9) | 3 (1, 9) | 4 (1, 9) |
| Failed induction therapy, n (%) | |||
| Cytarabine-based induction chemotherapy | N/A | N/A | 21 (70) |
| Alternative induction therapy | N/A | N/A | 3 (10) |
| ER, <6 mo | |||
| n (%) | 4 (9.5) | 6 (12) | 6 (20) |
| Median duration of CR (range), mo | N/A | 1.6 (0.8-5.1) | 1.6 (0.8-5.1) |
| BM blasts at time of study enrollment, median (range), % | 40 (2-98) | 46 (5-94) | 41 (5-94) |
| Baseline WBC, median (range), ×109/L | 2 (0.4-29.7) | 1.95 (0.3-67) | 2.35 (0.4-16.2) |
N/A, not applicable; WBC, white blood cell.
A subset of the RP2D patient population.