Table 3.
Response rates by study cohorts (dose escalation + dose expansion)
| Cohort | N | Composite response rate (CR + CRi) [n], n (%) | Overall response rate (CR + CRi + PR) [n], n (%) | Leukemia response rate (CR + CRi + PR + MLFS) [n], n (%) | Median duration of CR + CRi (95% CI) | Median OS (95% CI) |
|---|---|---|---|---|---|---|
| All patients | 145 | [54 + 43], 97 (67) | [54 + 43 + 2], 99 (68) | [54 + 43 + 2 + 21], 120 (83) | 11.3 (8.9-NR) | 17.5 (12.3-NR) |
| VEN 400 mg + HMA | 60 | 44 (73) | 44 (73) | 49 (82) | 12.5 (7.8-NR) | NR (11.0-NR) |
| VEN 400 mg + AZA | 29 | 22 (76) | 22 (76) | 24 (83) | NR (5.6-NR) | NR (9.0-NR) |
| VEN 400 mg + DEC | 31 | 22 (71) | 22 (71) | 25 (81) | 12.5 (5.1-NR) | 14.2 (7.7-NR) |
| VEN 800 mg + HMA | 74 | 48 (65) | 50 (68) | 63 (85) | 11.0 (6.5-12.9) | 17.5 (10.3-NR) |
| VEN 800 mg + AZA | 37 | 21 (57) | 22 (59) | 31 (84) | 11.7 (4.6-12.9) | 15.2 (9.1-NR) |
| VEN 800 mg + DEC | 37 | 27 (73) | 28 (76) | 32 (86) | 9.2 (5.9-NR) | 17.5 (10.3-NR) |
| VEN 1200 mg + HMA | 11 | 5 (45) | 5 (45) | 8 (73) | 9.4 (4.1-NR) | 11.4 (0.9-NR) |
| VEN 1200 mg + AZA | 6 | 2 (33) | 2 (33) | 4 (67) | 6.7 (4.1-9.4) | 8.8 (0.9-NR) |
| VEN 1200 mg + DEC | 5 | 3 (60) | 3 (60) | 4 (80) | NR (NR-NR) | NR (12.4-NR) |
Patients undergoing SCT (n = 21) were not censored from CR/CRi and OS analyses.