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) | ||
