Table 2.
Trial | Design | AML type | Age, median (range) | Risk Group | Response | Survival | Early mortality |
---|---|---|---|---|---|---|---|
FIA versus CIA | ELN 2010 | 2-year | |||||
FIA (N = 76) | Phase 2 | ND-AML | 49 (18–66) | int-2/adverse: 58% | ORR: 83%; CR/CRp: 82%; MRD-neg: 65% | 57% | 60 days: 1% |
CIA (N = 106) | Phase 2 | ND-AML | 53 (20–66) | int-2/adverse: 57% | ORR: 83%; CR/CRp: 80%; MRD-neg: 80% | 51% | 60 days: 4% |
FLAG-IDA versus ADE | Cytogenetic risk | 8-year | |||||
FLAG-IDA (N = 635) | Phase 3 | ND-AML | 48 (0–71) | Int: 69%, Adv: 13% | ORR: 86%, CR: 84% | 44% | Induction: 7% |
ADE (N = 633) | Phase 3 | ND-AML | 48 (0–67) | Int: 72%, Adv: 13% | ORR: 85%, CR: 81% | 37% | Induction: 7% |
DA versus DAC. versus DAF | SWOG criteria | 3-year | |||||
DAC (N = 222) | Phase 3 | ND-AML | 48 (18–60) | Int: 52%, Adv: 16% | ORR: 68%, CR: 62% | 45% | Induction: 11% |
DAF (N = 219) | Phase 3 | ND-AML | 47 (17–60) | Int: 51%, Adv: 18% | ORR: 59%, CR: 55% | 35% | Induction: 9% |
DA (N = 211) | Phase 3 | ND-AML | 47 (18–60) | Int: 50%, Adv: 18% | ORR: 56%, CR: 51% | 33% | Induction: 10% |
CPX-351 versus “7 + 3” | Mean (SD) | NCCN criteria | 5-year | ||||
CPX-351 (N = 153) | Phase 3 | sAML | 67.8 (4.2) | Int: 45%, Adv: 50% | CR/CRi: 48%, CR: 37% | 18% | 60 days: 13.7% |
“7 + 3” (N = 156) | Phase 3 | sAML | 67.7 (4.1) | Int: 40%, Adv: 57% | CR/CRi: 36%, CR: 30 | 8% | 60 days: 21.2% |
FLAG-IDA + VEN | ELN 2017 | 1-year | |||||
ND-AML (N = 29) | Phase 2 | ND-AML | 45 (20–65) | Int: 45%, Adv: 38% | ORR: 97%, CRc:90%, MRD-neg: 96% |
94% | 30 days: 0% |
R/R-AML (N = 16) | Phase 1b | R/R-AML | 51 (20–73) | Int: 13%, Adv: 50% | ORR: 75%, CRc: 75%, MRD-neg: 58% |
38% | 30 days: 0% |
R/R-AML (N = 23) | Phase 2 | R/R-AML | 47 (22–66) | Int: 13%, Adv: 61% | ORR: 70%, CRc: 61%, MRD-neg: 79% |
68% | 30 days: 0% |
CLIA + VEN | ELN 2017 | 1-year | |||||
Phase 1b/2 | ND-AML | 48 (37–56) | Int: 30%, Adv: 35% | ORR: 94%, CRc: 94%, MRD-neg: 71% |
85% | 60 days: 2% | |
“5 + 2”+VEN | ELN 2017 | median | |||||
Phase 1b | ND-AML | 72 (63–80) | Int: 31%, Adv: 49% | ORR: 72%, CR: 41% | 11.2 mo. | 30 days: 6% |