Table 2 Secondary outcomes of tumor response assessed by the independent radiology committee and investigators
Socazolimab plus EC group (N = 248) | Placebo plus EC group (N = 248) | |
|---|---|---|
Secondary outcomes assessed by IRC | ||
Progression free survival (PFS) | ||
Events, n (%) | 155 (62.5) | 185 (74.6) |
Median (95% CI) (months) | 5.55 (5.06–5.82) | 4.37 (4.27–4.70) |
Hazard ratio (95% CI) and one-sided pa | 0.569 (0.457–0.708), <0.0001 | |
6 months PFS % (95%CI) | 41.3 (34.2–48.2) | 21.9 (16.2–28.1) |
12 months PFS% (95%CI) | 18.2 (12.6–24.5) | 5.2 (2.5–9.4) |
Objective response rate (ORR), n (%) (95% CI) b | 176 (75.5) (69.5–80.9) | 160 (68.1) (61.7–74.0) |
Complete response (CR) n (%) | 0 | 0 |
Partial response (PR) n (%) | 176 (75.5) | 160 (68.1) |
Stable disease (SD) n (%) | 48 (20.6) | 54 (23.0) |
Duration of response (DoR) | ||
Median (95% CI) (months) | 4.44 (4.11–5.32) | 3.45 (3.06–4.11) |
DoR ≥ 6 months (%) | 33.3 | 18.7 |
DoR ≥ 12 months (%) | 20.5 | 5.5 |
Secondary outcomes assessed by investigators | ||
Progression free survival (PFS) | ||
Events, n (%) | 199 (80.2) | 214 (86.3) |
Median (95% CI) (months) | 5.32 (4.44–5.65) | 4.30 (4.17–4.40) |
Hazard ratio (95% CI) and one-sided pa | 0.653 (0.536–0.795), <0.0001 | |
6 months PFS % (95%CI) | 33.3 (27.0–39.7) | 21.2 (16.0–26.8) |
12 months PFS% (95%CI) | 12.2 (8.2–17.1) | 3.1 (1.3–6.2) |
Objective response rate (ORR), n (%) (95% CI) b | 165 (70.5) (64.2–76.3) | 154 (65.3) (58.8–71.3) |
Complete response (CR) n (%) | 0 | 0 |
Partial response (PR) n (%) | 165 (70.5) | 154 (65.3) |
Stable disease (SD) n (%) | 52 (22.2) | 53 (22.5) |
Duration of response (DoR) | ||
Median (95% CI) (months) | 4.24 (4.11–4.63) | 3.88 (3.02–4.11) |
DoR ≥ 6 months (%) | 42.0 | 22.9 |
DoR ≥ 12 months (%) | 19.8 | 3.9 |
