Patient baseline demographics and clinical characteristics by treatment arm
| Characteristic . | Arm A CPX-351 plus venetoclax (N = 27) . | Arm B CPX-351 plus midostaurin (N = 23) . | Arm C CPX-351 plus enasidenib (N = 7) . |
|---|---|---|---|
| Age, median (range), y | 57 (35-71) | 66 (40-74) | 50 (39-68) |
| 18-59, n (%) | 16 (59) | 5 (22) | 5 (71) |
| ≥60, n (%) | 11 (41) | 18 (78) | 2 (29) |
| Sex at birth, n (%) | |||
| Male | 15 (56) | 11 (48) | 3 (43) |
| Female | 12 (44) | 12 (52) | 4 (57) |
| Race, n (%) | |||
| White | 20 (74) | 18 (78) | 6 (86) |
| Black or African American | 3 (11) | 2 (9) | 0 |
| Asian | 2 (7) | 2 (9) | 1 (14) |
| Declined to state | 2 (7) | 1 (4) | 0 |
| Disease risk classification, n (%) | |||
| Favorable | 5 (19) | 1 (4) | 1 (14) |
| Intermediate | 8 (30) | 15 (65) | 4 (57) |
| Poor | 14 (52) | 7 (30) | 2 (29) |
| Positive for mutations, n (%) | |||
| FLT3-ITD | 1 (4)∗ | 18 (78) | 0 |
| FLT3-TKD | 0 | 5 (22) | 0 |
| NPM1 | 4 (15) | 16 (70) | 2 (29) |
| CBPA | 4 (15) | 1 (4) | 1 (14) |
| IDH1 | 1 (4) | 3 (13) | 0 |
| IDH2 | 0 | 2 (9) | 7 (100) |
| RUNX1 | 1 (4) | 2 (9) | 1 (14) |
| ASXL1 | 3 (11) | 2 (9) | 2 (29) |
| TP53 | 5 (19) | 0 | 0 |
| Other | 19 (70) | 9 (39) | 5 (71) |
| AML subtype,† n (%) | |||
| Newly diagnosed AML per WHO criteria | 27 (100) | 22 (96)‡ | 7 (100) |
| De novo AML | 19 (70) | 17 (74) | 5 (71) |
| Antecedent hematologic disorder§ | 7 (26) | 4 (17) | 2 (29) |
| Therapy-related AML | 4 (15) | 3 (13) | 0 |
| ECOG PS, n (%) | |||
| 0 | 11 (41) | 6 (26) | 5 (71) |
| 1 | 14 (52) | 15 (65) | 1 (14) |
| 2 | 2 (7) | 2 (9) | 1 (14) |
| Characteristic . | Arm A CPX-351 plus venetoclax (N = 27) . | Arm B CPX-351 plus midostaurin (N = 23) . | Arm C CPX-351 plus enasidenib (N = 7) . |
|---|---|---|---|
| Age, median (range), y | 57 (35-71) | 66 (40-74) | 50 (39-68) |
| 18-59, n (%) | 16 (59) | 5 (22) | 5 (71) |
| ≥60, n (%) | 11 (41) | 18 (78) | 2 (29) |
| Sex at birth, n (%) | |||
| Male | 15 (56) | 11 (48) | 3 (43) |
| Female | 12 (44) | 12 (52) | 4 (57) |
| Race, n (%) | |||
| White | 20 (74) | 18 (78) | 6 (86) |
| Black or African American | 3 (11) | 2 (9) | 0 |
| Asian | 2 (7) | 2 (9) | 1 (14) |
| Declined to state | 2 (7) | 1 (4) | 0 |
| Disease risk classification, n (%) | |||
| Favorable | 5 (19) | 1 (4) | 1 (14) |
| Intermediate | 8 (30) | 15 (65) | 4 (57) |
| Poor | 14 (52) | 7 (30) | 2 (29) |
| Positive for mutations, n (%) | |||
| FLT3-ITD | 1 (4)∗ | 18 (78) | 0 |
| FLT3-TKD | 0 | 5 (22) | 0 |
| NPM1 | 4 (15) | 16 (70) | 2 (29) |
| CBPA | 4 (15) | 1 (4) | 1 (14) |
| IDH1 | 1 (4) | 3 (13) | 0 |
| IDH2 | 0 | 2 (9) | 7 (100) |
| RUNX1 | 1 (4) | 2 (9) | 1 (14) |
| ASXL1 | 3 (11) | 2 (9) | 2 (29) |
| TP53 | 5 (19) | 0 | 0 |
| Other | 19 (70) | 9 (39) | 5 (71) |
| AML subtype,† n (%) | |||
| Newly diagnosed AML per WHO criteria | 27 (100) | 22 (96)‡ | 7 (100) |
| De novo AML | 19 (70) | 17 (74) | 5 (71) |
| Antecedent hematologic disorder§ | 7 (26) | 4 (17) | 2 (29) |
| Therapy-related AML | 4 (15) | 3 (13) | 0 |
| ECOG PS, n (%) | |||
| 0 | 11 (41) | 6 (26) | 5 (71) |
| 1 | 14 (52) | 15 (65) | 1 (14) |
| 2 | 2 (7) | 2 (9) | 1 (14) |
ECOG PS, Eastern Cooperative Oncology Group performance status; ITD, internal tandem duplications; TKD, tyrosine kinase domain; WHO, World Health Organization.
A protocol deviation resulted in 1 patient with low FLT3-ITD allelic ratio being enrolled into arm A.
Patients may have had multiple AML subtypes.
One patient in arm B had mixed-lineage leukemia and did not have newly diagnosed AML per WHO criteria.
Including 4 patients who had antecedent myelofibrosis.