Table 2.
Overall survival in patients with AML
| Overall population | de novo AML | Secondary AML | ||||
|---|---|---|---|---|---|---|
| Glasdegib + LDAC | LDAC alone | Glasdegib + LDAC | LDAC alone | Glasdegib + LDAC | LDAC alone | |
| All patients | n = 78 | n = 38 | n = 38 | n = 18 | n = 40 | n = 20 |
| Median OS, months (95% CI) | 8.3 (4.7–12.2) | 4.3 (1.9–5.7) | 6.6 (3.7–12.4) | 4.3 (1.3–10.7) | 9.1 (4.4–16.5) | 4.1 (1.5–6.4) |
| HR (95% CI) | 0.495 (0.325–0.752) | 0.720 (0.395–1.312) | 0.287 (0.151–0.548) | |||
| p value | 0.0004 | 0.1398 | < 0.0001 | |||
| Deaths, n (%) | ||||||
| Total | 69 (88.5) | 35 (92.1) | 33 (86.8) | 16 (88.9) | 36 (90.0) | 19 (95.0) |
| Cause of death: disease progression | 59 (75.6) | 29 (76.3) | 28 (73.7) | 12 (66.7) | 31 (77.5) | 17 (85.0) |
| Good/intermediate cytogenetic risk, n (%)a | 53 (67.9) | 22 (57.9) | 25 (65.8) | 14 (77.8) | 28 (70.0) | 8 (40.0) |
| Median OS, months (95% CI) | 12.2 (6.9–16.5) | 5.3 (3.5–8.7) | 12.2 (3.7–14.9) | 4.3 (1.3–10.7) | 11.1 (6.5–24.4) | 6.9 (4.1–8.1) |
| HR (95% CI) | 0.510 (0.294–0.886) | 0.603 (0.295–1.233) | 0.350 (0.135–0.907) | |||
| p value | 0.0074 | 0.0792 | 0.0121 | |||
| Deaths, n (%) | ||||||
| Total | 45 (84.9) | 19 (86.4) | 21 (84.0) | 12 (85.7) | 24 (85.7) | 7 (87.5) |
| Cause of death: disease progression | 37 (69.8) | 15 (68.2) | 16 (64.0) | 9 (64.3) | 21 (75.0) | 6 (75.0) |
| Poor cytogenetic risk, n (%)b | 25 (32.1) | 16 (42.1) | 13 (34.2) | 4 (22.2) | 12 (30.0) | 12 (60.0) |
| Median OS, months (95% CI) | 4.4 (2.6–7.4) | 2.1 (1.0–4.9) | 4.1 (1.9–8.8) | 4.4 (1.1–12.9) | 5.7 (0.2–9.1) | 1.8 (0.5–4.9) |
| HR (95% CI) | 0.514 (0.264–1.000) | 1.077 (0.337–3.441) | 0.301 (0.109–0.829) | |||
| p value | 0.0229 | 0.5495 | 0.0073 | |||
| Deaths, n (%) | ||||||
| Total | 24 (96.0) | 16 (100.0) | 12 (92.3) | 4 (100.0) | 12 (100.0) | 12 (100.0) |
| Cause of death: disease progression | 22 (88.0) | 14 (87.5) | 12 (92.3) | 3 (75.0) | 10 (83.3) | 11 (91.7) |
AML, acute myeloid leukemia; CI, confidence interval; HR, hazard ratio; LDAC, low-dose cytarabine; OS, overall survival
aFavorable, Intermediate I and Intermediate II risk groups
bAdverse risk group