Response by dose level
| Response, n (%) . | Dose level 1 (n = 4) . | Dose level 2 (n = 7) . | Dose level 1b (n = 24) . | Overall (N = 35) . |
|---|---|---|---|---|
| CR | 3 (75.0) | 3 (42.9) | 10 (41.7) | 16 (45.7) |
| CRi | 0 | 0 | 1 (4.2) | 1 (2.9) |
| PR | 0 | 0 | 1 (4.2) | 1 (2.9) |
| CRc∗,† | 3 (75.0) | 3 (42.9) | 11 (45.8) | 17 (48.6) |
| ORR‡ | 3 (75.0) | 3 (42.9) | 12 (50.0) | 18 (51.4) |
| First time to CR/CRi achieved at cycle 1 | 3 (75.0) | 3 (42.9) | 11 (45.8) | 17 (48.6) |
| MRD negativity achieved in patients with CR/CRi at any cycle | 3 (100.0) | 2 (66.7) | 9 (81.8) | 14 (82.4) |
| Unknown/missing response | 0 | 2 (28.6) | 2 (8.3) | 4 (11.4) |
| Response, n (%) . | Dose level 1 (n = 4) . | Dose level 2 (n = 7) . | Dose level 1b (n = 24) . | Overall (N = 35) . |
|---|---|---|---|---|
| CR | 3 (75.0) | 3 (42.9) | 10 (41.7) | 16 (45.7) |
| CRi | 0 | 0 | 1 (4.2) | 1 (2.9) |
| PR | 0 | 0 | 1 (4.2) | 1 (2.9) |
| CRc∗,† | 3 (75.0) | 3 (42.9) | 11 (45.8) | 17 (48.6) |
| ORR‡ | 3 (75.0) | 3 (42.9) | 12 (50.0) | 18 (51.4) |
| First time to CR/CRi achieved at cycle 1 | 3 (75.0) | 3 (42.9) | 11 (45.8) | 17 (48.6) |
| MRD negativity achieved in patients with CR/CRi at any cycle | 3 (100.0) | 2 (66.7) | 9 (81.8) | 14 (82.4) |
| Unknown/missing response | 0 | 2 (28.6) | 2 (8.3) | 4 (11.4) |
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.
CRc, composite complete remission rate; ORR, overall response rate; PR, partial response.
One patient who received dose level 1b with no response achieved 3.3% blasts by morphology after cycle 1 but was found to have persistent leukemia with ∼7.8% abnormal myeloid blasts on flow cytometry.
For patients to be classified as being in CRc at a postbaseline visit, they must either achieve CR or CRi at the visit. CRc rate is defined as the number of patients with CRc divided by the number of patients in the analysis population.
ORR is defined as the number of patients with CR or CRi or PR divided by the number of patients in the analysis population. Note, patients with an unknown or missing response, or who provide no information on response at the end of study were treated as nonresponders and included in the denominator when calculating percentages.