Antitumor activity assessed by sites investigators per RECIST V.1.1
| Antitumor activity | Total |
| N=58 | |
| ORR, n (%) (95% CI) * | 16 (27.6) (16.7 to 40.9) |
| DCR, n (%) (95% CI) * | 35 (60.3) (46.6 to 73.0) |
| Best overall response, n (%) | |
| Complete response | 0 (0.0) |
| Partial response | 16 (27.6) |
| Stable disease | 19 (32.8) |
| Progressive disease | 18 (31.0) |
| Not evaluable | 5 (8.6) |
| Time to response† months, median (range) | 1.4 (1.3–7.8) |
| Duration of response†‡ months, median (range) | 8.0 (1.5–12.5) |
| PFS‡, months, median (95% CI) | 4.2 (2.2 to 5.5) |
| 6-month rate (95% CI) | 28.3 (16.5 to 41.3) |
| OS‡, months, median (95% CI) | NR (8.7 to NR) |
| 12 month rate (95% CI) | 64.2 (49.4 to 75.7) |
*Based on the Clopper-Pearson exact method.
†Evaluated in patients who had a complete or partial response.
‡Estimated using the Kaplan-Meier method.
DCR, disease control rate; NR, not reached; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; RECIST, Response Evaluation Criteria In Solid Tumors.