Table 2.
Summary of efficacy (full analysis set, n = 82).
| Cohort 1 |
Cohort 2 |
Cohort 3 |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| 10 mg/kg Q3W (n = 19) | 20 mg/kg Q3W (n = 24) | Total (n = 43) | 10 mg/kg Q3W (n = 10) | 20 mg/kg Q3W (n = 9) | Total (n = 19) | 10 mg/kg Q3W (n = 10) | 20 mg/kg Q3W (n = 10) | Total (n = 20) | |
| ORR confirmed, n (%) | 10 (52.6) | 13 (54.2) | 23 (53.5) | 8 (80.0) | 5 (55.6) | 13 (68.4) | 4 (40.0) | 4 (40.0) | 8 (40.0) |
| 95% CI | [28.9–75.6] | [32.8–74.4] | [37.7–68.8] | [44.4–97.5] | [21.2–86.3] | [43.4–87.4] | 4 (40.0) | 4 (40.0) | [19.1–63.9] |
| DCR confirmed, n (%) | 17 (89.5) | 23 (95.8) | 40 (93.0) | 9 (90.0) | 9 (100.0) | 18 (94.7) | 7 (70.0) | 7 (70.0) | 14 (70.0) |
| 95% CI | [66.9–98.7] | [78.9–99.9] | [80.9–98.5] | [55.5–99.7] | [66.4–100.0] | [74.0–99.9] | [34.8–93.3] | [34.8–93.3] | [45.7–88.1] |
| DOR (months) | NR | NR | NR | 8.38 | 3.91 | 8.38 | NR | NR | NR |
| 95% CI | [2.79-NE] | [8.57-NE] | [11.07-NE] | [4.14-NE] | [2.76-NE] | [3.91-NE] | [8.54-NE] | [3.78-NE] | [3.78-NE] |
n, number; Q3W, every 3 weeks; ORR, objective response rate; DCR, disease control rate; DOR, duration of response; CI, confidence interval; NR, not reached; NE, not evaluable. Full analysis set: All subjects in the enrolled analysis set had received at least one study drug therapy and had a measurable lesion at baseline (as defined by RECIST v1.1). ORR was based on the full analysis set of subjects with at least one tumor evaluation after drug administration.