Patient demographics and baseline characteristics of the safety population
| . | ven-idasa, n = 55 . | ||
|---|---|---|---|
| DE, n = 49 . | DSO, n = 6 . | All patients, n = 55 . | |
| Median age, y (range) | 72.0 (62-93) | 69.0 (41-77) | 72.0 (41-93) |
| Male sex, n (%) | 32 (65) | 2 (33) | 34 (62) |
| ECOG PS, n (%) | |||
| 0 | 15 (31) | 2 (33) | 17 (31) |
| 1 | 26 (53) | 1 (17) | 27 (49) |
| 2 | 8 (16) | 3 (50) | 11 (20) |
| Disease status, n (%) | |||
| Refractory | 27 (55) | 4 (67) | 31 (56) |
| Relapse | 17 (35) | 2 (33) | 19 (35) |
| Newly diagnosed, transformed from AHD (previously treated) | 5 (10) | 0 (0) | 5 (9) |
| AML type, n (%) | |||
| De novo | 25 (51) | 5 (83) | 30 (55) |
| Secondary | 24 (49) | 1 (17) | 25 (45) |
| Median prior therapies, n (range) | 1 (1-4) | 3 (1-4) | 1 (1-4) |
| Previous HSCT, n (%) | 1 (2) | 1 (17) | 2 (4) |
| WBC at baseline, 109/L, median (range) | 2.2 (0.5-27.1) | 3.4 (1.4-8.4) | 2.4 (0.5-27.1) |
| Aspirate BM blast %, median (range) | 34.0 (7.0-100.0) | 88.0 (22.0-97.0) | 34.5 (7.0-100.0) |
| Cytogenetics, n (%) | |||
| TP53 mutation status | |||
| Mutation detected∗ | 9 (18) | 1 (17) | 10 (18) |
| Mutation undetected | 37 (76) | 5 (83) | 42 (76) |
| Not evaluable | 3 (6) | 0 (0) | 3 (5) |
| t(9;11)(p22;q23);MLLT3-MLL | 1 (2) | 0 (0) | 1 (2) |
| inv(3)(q21q26.2) or t(3;3)(q21;q26.2);RPN1-EVI1 | 1 (2) | 0 (0) | 1 (2) |
| −5 or del(5q) | 3 (6) | 0 (0) | 3 (5) |
| −7 | 4 (8) | 0 (0) | 4 (7) |
| Cytogenetic abnormalities not classified as favorable or adverse | 15 (31) | 1 (17) | 16 (29) |
| Complex karyotype | 11 (22) | 0 (0) | 11 (20) |
| . | ven-idasa, n = 55 . | ||
|---|---|---|---|
| DE, n = 49 . | DSO, n = 6 . | All patients, n = 55 . | |
| Median age, y (range) | 72.0 (62-93) | 69.0 (41-77) | 72.0 (41-93) |
| Male sex, n (%) | 32 (65) | 2 (33) | 34 (62) |
| ECOG PS, n (%) | |||
| 0 | 15 (31) | 2 (33) | 17 (31) |
| 1 | 26 (53) | 1 (17) | 27 (49) |
| 2 | 8 (16) | 3 (50) | 11 (20) |
| Disease status, n (%) | |||
| Refractory | 27 (55) | 4 (67) | 31 (56) |
| Relapse | 17 (35) | 2 (33) | 19 (35) |
| Newly diagnosed, transformed from AHD (previously treated) | 5 (10) | 0 (0) | 5 (9) |
| AML type, n (%) | |||
| De novo | 25 (51) | 5 (83) | 30 (55) |
| Secondary | 24 (49) | 1 (17) | 25 (45) |
| Median prior therapies, n (range) | 1 (1-4) | 3 (1-4) | 1 (1-4) |
| Previous HSCT, n (%) | 1 (2) | 1 (17) | 2 (4) |
| WBC at baseline, 109/L, median (range) | 2.2 (0.5-27.1) | 3.4 (1.4-8.4) | 2.4 (0.5-27.1) |
| Aspirate BM blast %, median (range) | 34.0 (7.0-100.0) | 88.0 (22.0-97.0) | 34.5 (7.0-100.0) |
| Cytogenetics, n (%) | |||
| TP53 mutation status | |||
| Mutation detected∗ | 9 (18) | 1 (17) | 10 (18) |
| Mutation undetected | 37 (76) | 5 (83) | 42 (76) |
| Not evaluable | 3 (6) | 0 (0) | 3 (5) |
| t(9;11)(p22;q23);MLLT3-MLL | 1 (2) | 0 (0) | 1 (2) |
| inv(3)(q21q26.2) or t(3;3)(q21;q26.2);RPN1-EVI1 | 1 (2) | 0 (0) | 1 (2) |
| −5 or del(5q) | 3 (6) | 0 (0) | 3 (5) |
| −7 | 4 (8) | 0 (0) | 4 (7) |
| Cytogenetic abnormalities not classified as favorable or adverse | 15 (31) | 1 (17) | 16 (29) |
| Complex karyotype | 11 (22) | 0 (0) | 11 (20) |
AHD, antecedent hematological disorder; ECOG PS, Eastern Cooperative Oncology Group performance status; HSCT, hematopoietic stem cell transplantation; WBC, white blood cells.
Using FM Heme cutoff of 1%.