Table 1.
Baseline and Prior Treatment Characteristics of Patients With R/R AML in the CHRYSALIS and ADMIRAL Trials.
| Characteristic | CHRYSALIS 120-/200-mg Gilteritinib | ADMIRAL 120-mg Gilteritinib vs salvage chemotherapy | ||||
|---|---|---|---|---|---|---|
| Prior TKI (n = 33) | No Prior TKI (n = 112) | Gilteritinib | Salvage chemotherapy | |||
| Prior TKI (n = 33) | No Prior TKI (n = 214) | Prior TKI (n = 15) | No Prior TKI (n = 109) | |||
| Median age, years (range) | 56 (24–84) | 61 (22–87) | 55 (20–82) | 62.5 (22–84) | 64 (34–78) | 61 (19–85) |
| Female, n (%) | 18 (55) | 59 (53) | 14 (42) | 117 (55) | 9 (60) | 61 (56) |
| ECOG performance status, n (%) | ||||||
| 0–1 | 22 (67) | 87 (78) | 25 (76) | 181 (85) | 14 (93) | 91 (84) |
| ≥2 | 11 (33) | 25 (22) | 8 (24) | 33 (15) | 1 (7) | 18 (17) |
| FLT3 mutation type, n (%) | ||||||
| FLT3-ITD only | 29 (88) | 94 (84) | 24 (73) | 191 (89) | 14 (93) | 99 (91) |
| FLT3-TKD only | 0 | 9 (8) | 5 (15) | 16 (8) | 1 (7) | 9 (8) |
| FLT3-ITD and -TKD | 4 (12) | 7 (6) | 4 (12) | 3 (1) | 0 | 0 |
| Other/unknown/missing | 0 | 2 (2) | 0 | 4 (2) | 0 | 1 (0.9) |
| Cytogenetic risk status, n (%) | ||||||
| Favorable | 0 | 4 (4) | 0 | 4 (2) | 0 | 1 (0.9) |
| Intermediate | 23 (70) | 78 (70) | 30 (91) | 152 (71) | 14 (93) | 75 (69) |
| Unfavorable | 4 (12) | 14 (13) | 3 (9) | 23 (11) | 1 (7) | 10 (9) |
| Other/unknown/missing | 6 (18) | 16 (14) | 0 | 35 (16) | 0 | 23 (21) |
| Response to first-line therapy, n (%) | ||||||
| Relapsed | 22 (67) | 74 (66) | 19 (61) | 130 (61) | 12 (80) | 64 (59) |
| Primary refractory | 11 (33) | 38 (34) | 14 (42) | 84 (39) | 3 (20) | 45 (41) |
| Prior lines of therapy, n (%) | ||||||
| 1 | 3 (9) | 42 (38) | 33 (100) | 215 (100) | 15 (100) | 109 (100) |
| 2 | 6 (18) | 36 (32) | 0 | 0 | 0 | 0 |
| ≥3 | 24 (73) | 34 (30) | 0 | 0 | 0 | 0 |
| Prior TKI, n (%) | ||||||
| Midostaurin | 0 | NA | 14 (42) | NA | 9 (60) | NA |
| Sorafenib | 33 (100) | 19 (58) | 6 (40) | |||
| Prior HSCT, n (%) | ||||||
| Yes | 14 (42) | 34 (30) | 10 (30) | 38 (18) | 4 (27) | 22 (20) |
| No | 19 (58) | 78 (70) | 23 (69) | 176 (82) | 11 (73) | 87 (80) |
| On-study HSCT, n (%) | ||||||
| Yes | 6 (18) | 24 (21) | 5 (15) | 59 (28) | 0 | 19 (17) |
| No | 27 (82) | 88 (79) | 29 (88) | 155 (72) | 15 (100) | 90 (83) |
| Posttransplant gilteritinib maintenance therapy, n (%) | ||||||
| Yes | 0 | 12 | 4 | 36 | NA | NA |
| No | 6 | 12 | 1 | 23 | NA | NA |
| Molecular Profile of Patients in the ADMIRAL Trial | ||||||
| FLT3-ITD allelic ratioa, n (%) | n = 28 | n = 194 | n = 14 | n = 99 | ||
| High | 14 (50) | 95 (49) | 6 (43) | 54 (55) | ||
| Low | 14 (50) | 99 (51) | 8 (57) | 45 (45) | ||
| Co-mutations, n (%) | n = 32 | n = 207 | n = 14 | n = 108 | ||
| NPM1 | 15 (47) | 100 (48) | 9 (64) | 49 (45) | ||
| DNMT3A | 9 (28) | 66 (32) | 6 (43) | 34 (31) | ||
| DNMT3A and NPM1 | 7 (22) | 48 (23) | 4 (29) | 27 (25) | ||
| WT1 | 10 (31) | 35 (17) | 4 (29) | 16 (15) | ||
| IDH1 or IDH2 | 4 (13) | 34 (16) | 4 (29) | 14 (13) | ||
aMeasured as the ratio of FLT3-ITD to FLT3 wild-type for all patients with a centrally confirmed FLT3-ITD mutation. A high FLT3-ITD allelic ratio was greater than or equal to the median value of 0.77 and a low FLT3-ITD allelic ratio was less than the median value of 0.77.
AML acute myeloid leukemia, ECOG Eastern Cooperative Oncology Group, HSCT hematopoietic stem cell transplantation, IRT interactive response technology, ITD internal tandem duplication, NA not applicable, R/R relapsed or refractory, TKD tyrosine kinase domain, TKI tyrosine kinase inhibitor.