Clinical response as assessed by investigator by phase and overall (SAF)
| Phase IA (n=116) | Phase IB (n=335) | Overall (n=451) | |
| ORR (CR, PR) | |||
| % (95% CI) | 18.1 (11.57 to 26.33) | 11.6 (8.41 to 15.57) | 13.3 (10.31 to 16.79) |
| Best overall confirmed response, n (%) | |||
| CR | 4 (3.4) | 2 (0.6) | 6 (1.3) |
| PR | 17 (14.7) | 37 (11.0) | 54 (12.0) |
| SD | 42 (36.2) | 99 (29.6) | 141 (31.3) |
| PD | 48 (41.4) | 152 (45.4) | 200 (44.3) |
| NE | 1 (0.9) | 6 (1.8) | 7 (1.6) |
| Missing | 4 (3.4) | 39 (11.6) | 43 (9.5) |
| DCR (CR, PR, SD) | |||
| n (%) | 63 (54.3) | 138 (41.2) | 201 (44.6) |
| Exact 95% CI | 44.81 to 63.59 | 35.87 to 46.67 | 39.92 to 49.29 |
| CBR (CR, PR, durable SD*) | |||
| n (%) | 35 (30.2) | 82 (24.5) | 117 (25.9) |
| Exact 95% CI | 22.00 to 39.39 | 19.97 to 29.45 | 21.96 to 30.25 |
| Time to response (months) | |||
| N | 21 | 39 | 60 |
| Median (range) | 2.2 (1.8 to 15.9) | 2.2 (1.3 to 10.2) | 2.2 (1.3 to 15.9) |
*Durable SD is defined as SD with duration ≥24 weeks.
CBR, clinical benefit rate; CR, complete response; DCR, disease control rate; NE, not estimable; ORR, objective response rate; PD, progressive disease; PR, partial response; SAF, safety analysis set; SD, stable disease.