TABLE 5.
Clinical Response Among the Response-Evaluable Population
| Schedule 1, <1.25 mg/m2 FIL or BTZ = 1.0 N = 26 | Schedule 1, ≥1.25 mg/m2 FIL and BTZ = 1.3 N = 19 | Schedule 2 N = 10 | Total Treated N = 55 | |
|---|---|---|---|---|
| Best disease response Stringent CR | 0 (0) | 1 (5) | 0 (0) | 1 (2) |
| Very good PR | 0 (0) | 4 (21) | 1 (10) | 5 (9) |
| PR | 1 (4) | 3 (16) | 1 (10) | 5 (9) |
| MR | 2 (8) | 3 (16) | 2 (20) | 7 (13) |
| SD | 18 (69) | 9 (47) | 7 (70) | 34 (62) |
| SD ≥8 wk | 11 (42) | 3 (16) | 4 (40) | 18 (33) |
| PD | 6 (23) | 2 (11) | 1 (10) | 9 (16) |
| NE | 1 (4) | 0 (0) | 0 (0) | 1 (2) |
| ORR (≥ PR) | 1 (4) | 8 (42) | 2 (20) | 11 (20) |
| Median time on study (95% CI), mo | NR (NR-NR) | 20.9 (6.9–30) | 16.6 (7.4–13.9) | 16.7 (6.9-NR) |
| CBR (≥MR) | 3 (11) | 11 (58) | 4 (40) | 18 (33) |
| Median time on study (95% CI), mo | 14.5 (6.6-NR) | 13.0 (6.9–30) | 13.0 (7.4–14.5) | 13.4 (9.9–16.9) |
| DCR (≥SD[>8 wk]) | 14 (54) | 14 (74) | 8 (80) | 36 (65) |
| Median time on study (95% CI), mo | 5.4 (3.0–14.5) | 12.8 (6.9–25.1) | 8.5 (4.2–13.9) | 9.3 (6.9–13.0) |
Abbreviations: 95% CI, 95% confidence interval; BTZ, bortezomib; CBR, clinical benefit rate; CR, complete response; DCR, disease control rate; FIL, filanesib; MR, minimal response; NE, not evaluable; NR, not reached; ORR, overall response rate; PD, progressive disease; PR, partial response; SD, stable disease.