Table 5.
Efficacy outcomes by subgroups
| Subgroup | Evaluable for response/OS, n (%) | CR + CRi, n (%) | n for Median duration of CR + CRi | Median duration of CR + CRi, mo (95%CI) | Median OS, mo (95%CI) |
|---|---|---|---|---|---|
| All patients | 145 | 97 (67) | 97 | 11.3 (8.9, NR) | 17.5 (12.3-NR) |
| Cytogenetic risk | |||||
| Intermediate | 74 (51) | 55 (74) | 55 | 12.9 (11, NR) | NR (17.5-NR) |
| Poor | 71 (49) | 42 (60) | 42 | 6.7 (4.1, 9.4) | 9.6 (7.2-12.4) |
| Age | |||||
| ≥75 y | 62 (43) | 40 (65) | 40 | 9.2 (6.4, 12.5) | 11 (9.3-NR) |
| <75 y | 83 (57) | 57 (69) | 57 | 12.9 (9.2, NR) | 17.7 (14.2-NR) |
| AML | |||||
| De novo | 109 (75) | 73 (67) | 73 | 9.4 (7.2, 11.7) | 12.5 (10.3-24.4) |
| Secondary | 36 (25) | 24 (67) | 24 | NR (12.5, NR) | NR (14.6-NR) |
| Mutations* | |||||
| FLT3† | 18 (12) | 13 (72) | 13 | 11 (6.5, NR) | NR (8-NR) |
| IDH1 or 2‡ | 35 (24) | 25 (71) | 25 | NR (6.8, NR) | 24.4 (12.3-NR) |
| NPM1 | 23 (16) | 21 (91) | 21 | NR (6.8, NR) | NR (11-NR) |
| TP53 | 36 (25) | 17 (47) | 17 | 5.6 (1.2, 9.4) | 7.2 (3.7-NR) |
ITD, internal tandem duplication; TKD, tyrosine kinase domain.
*
Determined by central laboratory in 141/145 of patients.
†
FLT3-ITD mutations were identified in 10 patients, FLT3-TKD in 6 patients; 1 patient had both FLT3-ITD and TKD, 1 patient had atypical TKD mutation at S451, and 1 patient had an amplification of FLT3.
‡
IDH1R132 mutations were identified in 15 patients, IDH2R140 in 13 patients, IDH2R172 in 6 patients, and 1 patient in a nonhotspot mutation in IDH2K282.