Table 2 Response outcomes
|  | All(n = 96) | Refractory AML (n = 37) | Relapsed AML after chemotherapy (n = 16) | Relapsed AML after allo-HSCT (n = 43) | P |
|---|---|---|---|---|---|
CRc (CR + CRi), No. (% [95% CI]) | 68 (70.8[60.8–79.2]) | 29 (78.4[61.9–89.0]) | 10 (62.5[36.6–82.8]) | 29 (67.4[51.9–79.9]) | 0.407 |
CR, No. (%) | 40 (41.7) | 19 (51.4) | 8 (50.0) | 13 (30.2) | Â |
CRi, No. (%) | 28 (29.2) | 10 (27.0) | 2 (12.5) | 16 (37.2) | Â |
MRD- CRc, No. (%)†| 40 (58.8) | 17 (58.6) | 5 (50.0) | 18 (62.1) | 0.799 |
PR, No. (%) | 7 (7.3) | 1 (2.7) | 1 (6.3) | 5 (11.6) | Â |
NR, No. (%) | 21 (21.9) | 7 (18.9) | 5 (31.3) | 9 (20.9) | Â |
ORR, No. (% [95% CI]) | 75 (78.1[68.6–85.4]) | 30 (81.1[64.8–90.9]) | 11 (68.8[42.1–86.9]) | 34 (79.1[64.0–88.9]) | 0.596 |
CRc at Cycle 1, No. (% [95% CI]) | 56 (58.3[48.1–67.9]) | 27 (73.0[56.2–85.0]) | 7 (43.8[21.7–68.6]) | 22 (51.2[36.2–65.9]) | 0.062 |
ORR at Cycle 1, No. (% [95% CI]) | 69 (71.9[61.9–80.1]) | 30 (81.1[64.8–90.9]) | 9 (56.3[31.4–78.3]) | 30 (69.8[54.2–81.8]) | 0.167 |
EFS | |||||
 Median, months (95% CI) | 14.3 (7.0 to NE) | Not reached | 7.8 (2.0 to NE) | 6.0 (2.3 to NE) | 0.182 |
 12-months, % (95% CI) | 51.0 (40.7–60.5) | 64.9 (47.3–77.9) | 43.8 (19.8–65.6) | 41.9 (27.1–55.9) | 0.099 |
 Estimated 24-months, % (95% CI) | 46.0 (34.0–57.2) | 54.1 (32.8–71.2) | 43.8 (19.8–65.6) | 41.9 (27.1–55.9) | 0.182 |
OS | |||||
 Median, months (95% CI) | 22.1 (12.7 to NE) | Not reached | 22.1 (3.0 to NE) | 15.4 (6.8 to NE) | 0.114 |
 12-months, % (95% CI) | 61.5 (51.0–70.4) | 70.3 (52.8–82.3) | 56.3 (29.5–76.2) | 55.8 (39.9–69.1) | 0.345 |
 Estimated 24-months, % (95% CI) | 47.2 (33.3–59.8) | 63.2 (41.9–78.6) | 37.5 (8.4–67.8) | 34.3 (14.6–56.4) | 0.114 |