Table 3. Best response and outcomes after 1-2 cycles of study therapy.
| Response | All patients (n=52) | Patients treated at/above RP2D (n=46) |
|---|---|---|
|
| ||
| CR, n (%) | 11 (21.2%) | 10 (21.7%) |
| MRDneg | 9 (17.3%) | 8 (17.4%) |
| MRDpos | 2 (3.8%) | 2 (4.3%) |
|
| ||
| CRp, n (%) | 7 (13.5%) | 5 (10.9%) |
| MRDneg | 4 (7.7%) | 3 (6.5%) |
| MRDpos | 3 (5.8%) | 2 (4.3%) |
|
| ||
| Overall remission rate (CR+CRp), n (%) | 18 (34.6%) | 15 (32.6%) |
|
| ||
| CRi, n (%) | 1 (1.9%) | 1 (2.2%) |
| MRDneg | 0 (0%) | 0 (0%) |
| MRDpos | 1 (1.9%) | 1 (2.2%) |
|
| ||
| Morphologic leukemia-free state, n (%) | 7 (13.5%) | 7 (15.2%) |
| MRDneg | 3 (5.8%) | 3 (6.5%) |
| MRDpos | 4 (7.7%) | 4 (8.7%) |
|
| ||
| Resistant disease, n (%) | 21 (40.3%) | 20 (43.5%) |
|
| ||
| Death from indeterminate cause, n (%) | 5 (9.6%) | 3 (6.5%) |
|
| ||
| Early death**, n (5) | 9 (17.3%) | 7 (15.2%) |
|
| ||
| 8-week mortality, n (%) | 11 (21.2%) | 9 (19.6%) |
|
| ||
| Median overall survival, months | 5 | 5 |
|
| ||
| Median relapse-free survival, months | 5 | 5 |
*
2 patients died prior to receiving MEC;
**
Death within 28 days of initiation of study therapy
Abbreviation: CR, complete remission; CRi, complete remission with incomplete blood count recovery; CRp, complete remission with incomplete platelet recovery; MRD, measurable residual disease; RP2D, recommended phase 2 dose