Best overall responses at any time during the study in the FAS
| Responsecategory . | Ivosidenib 500 mg + chemotherapy, n (%) . | Enasidenib 100 mg + chemotherapy, n (%) . | ||||
|---|---|---|---|---|---|---|
| All,N = 60 . | De novo AML,n = 42 . | Secondary AML,n = 18 . | All,N = 91* . | De novo AML,n = 56 . | Secondary AML,n = 35 . | |
| CR/CRi/CRp | 46 (77) | 37 (88) | 9 (50) | 67 (74) | 45 (80) | 22 (63) |
| CR | 41 (68) | 32 (76) | 9 (50) | 50 (55) | 36 (64) | 14 (40) |
| CRi/CRp | 5 (8) | 5 (12) | — | 17 (19) | 9 (16) | 8 (23) |
| MLFS | 4 (7) | 3 (7) | 1 (6) | 10 (11) | 5 (9) | 5 (14) |
| PR | 2 (3) | — | 2 (11) | 2 (2) | 1 (2) | 1 (3) |
| Treatment failure† | 8 (13) | 2 (5) | 6 (33) | 12 (13) | 5 (9) | 7 (20) |
| Responsecategory . | Ivosidenib 500 mg + chemotherapy, n (%) . | Enasidenib 100 mg + chemotherapy, n (%) . | ||||
|---|---|---|---|---|---|---|
| All,N = 60 . | De novo AML,n = 42 . | Secondary AML,n = 18 . | All,N = 91* . | De novo AML,n = 56 . | Secondary AML,n = 35 . | |
| CR/CRi/CRp | 46 (77) | 37 (88) | 9 (50) | 67 (74) | 45 (80) | 22 (63) |
| CR | 41 (68) | 32 (76) | 9 (50) | 50 (55) | 36 (64) | 14 (40) |
| CRi/CRp | 5 (8) | 5 (12) | — | 17 (19) | 9 (16) | 8 (23) |
| MLFS | 4 (7) | 3 (7) | 1 (6) | 10 (11) | 5 (9) | 5 (14) |
| PR | 2 (3) | — | 2 (11) | 2 (2) | 1 (2) | 1 (3) |
| Treatment failure† | 8 (13) | 2 (5) | 6 (33) | 12 (13) | 5 (9) | 7 (20) |
MLFS, morphologic leukemia-free state.
Two patients assigned to receive enasidenib starting on day 8 had an ongoing adverse event or died on day 8 and thus never received enasidenib; these 2 patients were not included in the FAS used for efficacy analyses.
Treatment failure = stable disease + progressive disease + discontinuation before response assessment on or after induction day 21 + discontinuation with best response of not evaluable.