Table 4.
Analysis of investigator-assessed response rates by subgroup.
| Venetoclax +LDAC | Placebo + LDAC | |||||||
|---|---|---|---|---|---|---|---|---|
| N | CR, n (%) | CR/CRi, n (%) | CR/CRh, n (%) | N | CR, n (%) | CR/CRi, n (%) | CR/CRh, n (%) | |
| Age | ||||||||
| 18 to <75 years | 61 | 17 (27.9) | 28 (45.9) | 27 (44.3) | 28 | 2 (7.1) | 4 (14.3) | 4 (14.3) |
| ≥75 years | 82 | 23 (28.0) | 41 (50.0) | 42 (51.2) | 40 | 3 (7.5) | 5 (12.5) | 6 (15.0) |
| Cytogenetic riska | ||||||||
| Intermediate | 90 | 29 (32.2) | 51 (56.7) | 50 (55.6) | 43 | 4 (9.3) | 7 (16.3) | 8 (18.6) |
| Poor | 47 | 8 (17.0) | 13 (27.7) | 15 (31.9) | 20 | 1 (5.0) | 2 (10.0) | 2 (10.0) |
| AML type | ||||||||
| De novo | 85 | 31 (36.5) | 47 (55.3) | 50 (58.8) | 45 | 5 (11.1) | 8 (17.8) | 9 (20.0) |
| Secondary | 58 | 9 (15.5) | 22 (37.9) | 19 (32.8) | 23 | 0 | 1 (4.3) | 1 (4.3) |
| Prior HMA treatment | ||||||||
| Yes | 28 | 2 (7.1) | 8 (28.6) | 6 (21.4) | 14 | 0 | 1 (7.1) | 1 (7.1) |
| No | 115 | 38 (33.0) | 61 (53.0) | 63 (54.8) | 54 | 5 (9.3) | 8 (14.8) | 9 (16.7) |
aSeven total patients (n = 5 venetoclax arm, n = 2 placebo arm) had missing cytogenetic risk profiles. Four total patients were deemed to have favorable cytogenetic risk (n = 1 venetoclax, n = 3 placebo) and their response data were not presented due to small sample size.
AML, acute myeloid leukemia, CR complete response, CRh CR with partial hematologic recovery, CRi CR with incomplete hematologic recovery, HMA hypomethylating agent, LDAC low-dose cytarabine.