Table 2.
Outcomes with 10-day decitabine and venetoclax in AML
| Outcomes | Treatment-naïve patients | Previously treated patients | ||
|---|---|---|---|---|
| Newly Diagnosed AML (N=70) | Untreated Secondary AML (N=15) | Treated Secondary AML (N=28) | Relapsed or Refractory AML (N=55) | |
| Overall response rate (ORR) | 62 (89 [79, 94]) | 12 (80 [55, 93]) | 17 (61 [42, 76]) | 34 (62 [49, 74]) |
| CR | 46 (66 [54, 76]) | 6 (40 [20, 64]) | 6 (21 [10, 40]) | 13 (24 [14, 36]) |
| CRi | 13 (19 [11, 29]) | 4 (27 [11, 52]) | 5 (18 [8, 36]) | 10 (18 [10, 30]) |
| CR/CRi | 59 (84 [74, 91]) | 10 (67 [42, 85]) | 11 (39 [24, 56]) | 23 (42 [30, 55]) |
| MRD negative1,2 | 35/52 (67 [54, 79]) | 4/10 (40 [17, 69]) | 7/15 (47 [25, 70]) | 14/26 (54 [36, 71]) |
| Morphologic leukemia-free state | 3 (4 [2, 12]) | 2 (13 [4, 39]) | 6 (21 [10, 40]) | 10 (18 [10, 30) |
| No response | 8 (11 [6, 21]) | 3 (20 [7, 45]) | 10 (36 [21, 54]) | 15 (27 [17, 40]) |
| Inevaluable | 0 (0) | 0 (0) | 1 (4) | 6 (11) |
| Death prior to first evaluation | 0 (0) | 0 (0) | 1 (4) | 4 (7) |
| Complete cytogenetic response2,3 | 17/30 (57 [39, 73]) | 5/11 (46 [21, 72]) | 1/13 (8 [1, 33]) | 8/29 (28 [15, 46]) |
| Cycle 1 day 21 (±3) BM blasts ≤5%4 | 33/49 (67 [53, 79]) | 8/10 (80 [49, 94]) | 8/21 (38 [21, 59]) | 14/32 (44 [28, 61]) |
| Time to response, months | 1∙5 (1∙3, 1∙7) | 1∙3 (0∙9, 2∙2) | 1∙7 (1∙1, 2∙6) | 1∙8 (1∙4, 2∙0) |
| No∙ of cycles to response | 1 [1–2] | 1 [1–2] | 1 [1–2] | 1[1–2] |
| No∙ of cycles | 3 [2–7] | 3 [2–4] | 2 [1–3] | 2 [1–3] |
| administered Second cycle of 10-day decitabine | 8 (11) | 2 (13) | 8 (29) | 16 (29) |
All percentages are based on total number of patients in each cohort (N), unless specified. Results are reported as n (% [95% CI]) or median [interquartile range] or median (95% confidence interval). CR = complete remission, CRi = CR with incomplete hematologic recover, MRD = minimal residual disease, BM = bone marrow
Measured by multicolor flow cytometry validated to a sensitivity level of 0·01 to 0·1% (1 cell in 1,000 to 10,000),
The discrepancy in the numerators and denominators of patients undergoing MRD testing and conventional cytogenetics was related to the number of bone marrow samples with adequate specimen required for acquisition of 200,000 events needed for valid negative result, and the yield of sufficient number of metaphases for karyotyping.
Calculated at the time of best response, and only for patients with abnormal karyotype at screening and evaluable karyotype at response,
Includes patients with evaluable cycle 1 day 21 bone marrow sample.