Table 3 Efficacy of BPI-9016M in FAS
BOR, n (%) | Part A | Part B | Total (n = 38) n (%) | ||
|---|---|---|---|---|---|
300 mg QD (n = 12) | 450 mg QD (n = 12) | 600 mg QD (n = 10) | 400 mg BID (n = 4) | ||
CR | 0 | 0 | 0 | 0 | 0 |
PR | 0 | 0 | 1 (10.0) | 0 | 1 (2.6) |
SD | 5 (41.7) | 4 (33.3) | 3 (30.0) | 3 (75.0) | 15 (39.5) |
PD | 7 (58.3) | 6 (50.0) | 2 (20.0) | 0 | 15 (39.5) |
NE | 0 | 2 (16.7) | 4 (40.0) | 1 (25.0) | 7 (18.4) |
ORR (95% CI) | 0 (0, 26.5) | 0 (0, 26.5) | 10.0 (0.3, 44.5) | 0 (0, 60.2) | 2.6 (0.1, 13.8) |
DCR (95% CI) | 41.7 (15.2, 72.3) | 33.3 (9.9, 65.1) | 40.0 (12.2, 73.8) | 75.0 (19.4, 99.4) | 42.1 (26.3, 59.2) |
PFS, months | |||||
 Median (95% CI) | 1.9 (1.9, 5.6) | 1.9 (1.1, 3.8) | 1.8 (1.2, 3.9) | 3.4 (3.2, 3.7) | 1.9 (1.9, 3.7) |
OS, months | |||||
 Median (95% CI) | NE (4.0, NE) | 9.3 (2.6, NE) | NE (2.6, NE) | NE (NE, NE) | 10.3 (7.3, NE) |