Patient demographic and baseline characteristics by dose level
| . | Dose level 1 (n = 4) . | Dose level 2 (n = 7) . | Dose level 1b (n = 24) . | Overall (N = 35) . |
|---|---|---|---|---|
| Age, median (range), y | 82.5 (74-87) | 74.0 (65-89) | 74.0 (59-90) | 74.0 (59-90) |
| Age category, ≥75 y, n (%) | 3 (75.0) | 3 (42.9) | 10 (41.7) | 16 (45.7) |
| Sex, male,∗ n (%) | 3 (75.0) | 5 (71.4) | 13 (54.2) | 21 (60.0) |
| Race, n (%) | ||||
| Black or African American | 0 | 0 | 3 (12.5) | 3 (8.6) |
| White | 4 (100.0) | 6 (85.7) | 18 (7.0) | 28 (80.0) |
| Other | 0 | 1 (14.3) | 3 (12.5) | 4 (11.4) |
| AML subtype, n (%) | ||||
| De novo AML | 2 (50.0) | 6 (85.7) | 19 (79.2) | 27 (77.1) |
| Antecedent hematologic disorder | 1 (25.0) | 0 | 4 (16.7) | 5 (14.3) |
| Therapy-related AML | 1 (25.0) | 1 (14.3) | 1 (4.2) | 3 (8.6) |
| ECOG performance status, n (%) | ||||
| ≤1 | 4 (100.0) | 4 (57.1) | 15 (62.5) | 23 (65.7) |
| 2 | 0 | 3 (42.9) | 9 (37.5) | 12 (34.3) |
| 2017 ELN disease risk classification, n (%) | ||||
| Favorable | 0 | 2 (28.6) | 2 (8.3) | 4 (11.4) |
| Intermediate | 2 (50.0) | 2 (28.6) | 8 (33.3) | 12 (34.3) |
| Poor | 2 (50.0) | 3 (42.9) | 14 (58.3) | 19 (54.3) |
| Mutational analyses, n (%) | ||||
| TP53 | 1 (25.0) | 1 (14.3) | 6 (25.0) | 8 (22.9) |
| ASXL1 | 0 | 2 (28.6) | 5 (20.8) | 7 (20.0) |
| IDH2 | 0 | 2 (28.6) | 4 (16.7) | 6 (17.1) |
| NPM1 | 1 (25.0) | 1 (14.3) | 4 (16.7) | 6 (17.1) |
| RUNX1 | 0 | 2 (28.6) | 4 (16.7) | 6 (17.1) |
| IDH1 | 2 (50.0) | 1 (14.3) | 2 (8.3) | 5 (14.3) |
| FLT3-ITD | 0 | 0 | 3 (12.5) | 3 (8.6) |
| CEPBA | 0 | 0 | 2 (8.3) | 2 (5.7) |
| . | Dose level 1 (n = 4) . | Dose level 2 (n = 7) . | Dose level 1b (n = 24) . | Overall (N = 35) . |
|---|---|---|---|---|
| Age, median (range), y | 82.5 (74-87) | 74.0 (65-89) | 74.0 (59-90) | 74.0 (59-90) |
| Age category, ≥75 y, n (%) | 3 (75.0) | 3 (42.9) | 10 (41.7) | 16 (45.7) |
| Sex, male,∗ n (%) | 3 (75.0) | 5 (71.4) | 13 (54.2) | 21 (60.0) |
| Race, n (%) | ||||
| Black or African American | 0 | 0 | 3 (12.5) | 3 (8.6) |
| White | 4 (100.0) | 6 (85.7) | 18 (7.0) | 28 (80.0) |
| Other | 0 | 1 (14.3) | 3 (12.5) | 4 (11.4) |
| AML subtype, n (%) | ||||
| De novo AML | 2 (50.0) | 6 (85.7) | 19 (79.2) | 27 (77.1) |
| Antecedent hematologic disorder | 1 (25.0) | 0 | 4 (16.7) | 5 (14.3) |
| Therapy-related AML | 1 (25.0) | 1 (14.3) | 1 (4.2) | 3 (8.6) |
| ECOG performance status, n (%) | ||||
| ≤1 | 4 (100.0) | 4 (57.1) | 15 (62.5) | 23 (65.7) |
| 2 | 0 | 3 (42.9) | 9 (37.5) | 12 (34.3) |
| 2017 ELN disease risk classification, n (%) | ||||
| Favorable | 0 | 2 (28.6) | 2 (8.3) | 4 (11.4) |
| Intermediate | 2 (50.0) | 2 (28.6) | 8 (33.3) | 12 (34.3) |
| Poor | 2 (50.0) | 3 (42.9) | 14 (58.3) | 19 (54.3) |
| Mutational analyses, n (%) | ||||
| TP53 | 1 (25.0) | 1 (14.3) | 6 (25.0) | 8 (22.9) |
| ASXL1 | 0 | 2 (28.6) | 5 (20.8) | 7 (20.0) |
| IDH2 | 0 | 2 (28.6) | 4 (16.7) | 6 (17.1) |
| NPM1 | 1 (25.0) | 1 (14.3) | 4 (16.7) | 6 (17.1) |
| RUNX1 | 0 | 2 (28.6) | 4 (16.7) | 6 (17.1) |
| IDH1 | 2 (50.0) | 1 (14.3) | 2 (8.3) | 5 (14.3) |
| FLT3-ITD | 0 | 0 | 3 (12.5) | 3 (8.6) |
| CEPBA | 0 | 0 | 2 (8.3) | 2 (5.7) |
Dose level 1 included CPX-351, daunorubicin 8.8 mg/m2, and cytarabine 20 mg/m2 on days 1 and 3, plus venetoclax 400 mg on days 2 to 21. Dose level 2 included CPX-351, daunorubicin 17.6 mg/m2, and cytarabine 40 mg/m2 on days 1 and 3, plus venetoclax 400 mg on days 2 to 21. Dose level 1b included CPX-351, daunorubicin 13.2 mg/m2, and cytarabine 30 mg/m2 on days 1 and 3, plus venetoclax 400 mg on days 2 to 21.
ELN, European LeukemiaNet.
Sex was assigned at birth.