TABLE 3.
Response
| Parameter | Efficacy Population (n = 57) |
|---|---|
| Overall response rate, No. (%)a | 36 (63.2) |
| 95% CI | 49.3 to 75.6 |
| Time to first response, months, median (range) | 0.95 (0.9-2.0) |
| Duration of response, months, median (range) | 4.3 (1.9-NR) |
| CR + CRh rate, No. (%) | 13 (22.8) |
| 95% CI | 12.7 to 35.8 |
| P value, one-sided | 0.0036 |
| Time to first CR + CRh, months, median (range) | 1.87 (0.9-4.6) |
| Duration of CR + CRh, months, median (95% CI) | 6.4 (3.4 to NR) |
| CRc, No. (%)b | 25 (43.9) |
| 95% CI | 30.7 to 57.6 |
| Best response, No. (%) | |
| CR | 10 (17.5) |
| CRh | 3 (5.3) |
| CRi | 1 (1.8) |
| CRp | 11 (19.3) |
| Morphological leukemia-free state | 10 (17.5) |
| Partial remission | 1 (1.8) |
| Progressive disease | 4 (7.0) |
| No response | 14 (24.6) |
| Otherc | 3 (5.3) |
| MRD negative rate within evaluable patientsd | |
| Within CR + CRh, No. (%) | 7/10 (70.0) |
| Within CRc, No. (%) | 15/22 (68.2) |
| Time to negative MRD status for patients with CR + CRh, months, median (range) | 1.08 (1.0-3.9) |
NOTE. Data cutoff: July 24, 2023.
Abbreviations: CR, complete remission; CRc, composite complete remission; CRh, complete remission with partial hematologic recovery; CRi, complete remission with incomplete hematologic recovery; CRp, complete remission with incomplete platelet recovery; MRD, measurable residual disease.
a
Overall response rate was defined as CRc + morphological leukemia-free state + partial remission.
b
Composite CR defined as CR + CRh + CRi + CRp.
c
Includes patients without postbaseline disease assessment.
d
MRD done locally by flow cytometry; not all patients had MRD status reported. Available flow cytometry details for reported patients can be found in the Data Supplement (Table S2).