Table 3.
Cohort | ||||||
---|---|---|---|---|---|---|
Ven 400 mg | Ven 600 mg | Ven 800 mg | ||||
Response, n(%) | Alvo 45 mg/m2: “no ramp-up” (N = 8) | Alvo 45 mg/m2 (N = 6) | Alvo 60 mg/m2 (N = 11) | Alvo 60 mg/m2 (N = 5) | Alvo 60 mg/m2 (N = 5) | Total (N = 35) |
CR | 1 (12.5) | 0 | 0 | 0 | 0 | 1 (2.9) |
CRi | 0 | 0 | 2 (18.2) | 1 (20.0) | 0 | 3 (8.6) |
CR + CRi | 1 (12.5) | 0 | 2 (18.2) | 1 (20.0) | 0 | 4 (11.4) |
MLFS | 0 | 0 | 0 | 2 (40.0) | 1 (20.0) | 3 (8.6) |
Median Time to best response, months (range) | ||||||
CR | 1.2 (1.2–1.2) | NA | NA | NA | NA | 1.2 (1.2-1.2) |
CRi | NA | NA | 0.9 (0.8–0.9) | 1.0 (1.0–1.0) | NA | 0.9 (0.8–1.0) |
CR + CRi | 1.2 (1.2–1.2) | NA | 0.9 (0.8–0.9) | 1.0 (1.0–1.0) | NA | 0.9 (0.8–1.2) |
Objective Response Rate (CR + CRi + PR), n (%) | 1 (12.5) | 0 | 2 (18.2) | 1 (20.0) | 0 | 4 (11.4) |
Leukemia Response Rate (CR + CRi + PR + MLFS), n (%) | 1 (12.5) | 0 | 2 (18.2) | 3 (60.0) | 1 (20.0) | 7 (20.0) |
Median DoR for CR + CRi, months (95%CI) | 6.8 (5.1–NE) | 8.3 (NE–NE) | 8.4 (5.1–NE) |
Alvo, alvocidib; CR, complete remission; CRi, CR+incomplete blood count recovery; DoR, duration of response; MLFS, morphologic leukemia-free state; PR, partial remission; Ven, venetoclax