Table 2.
Tumor response and efficacy endpoints for all patients.
| Characteristics | All patients N = 85 | ICI+Lenva N = 58 | ICI+Others N = 27 | P value |
|---|---|---|---|---|
| CR, N (%) | 0 (0) | 0 (0) | 0 (0) | |
| PR, N (%) | 9 (10.6) | 8 (13.8) | 1 (3.7) | |
| SD, N (%) | 36 (42.4) | 22 (37.9) | 14 (51.9) | |
| PD, N (%) | 36 (42.4) | 26 (44.8) | 10 (37.0) | |
| NE, N (%) | 4 (4.7) | 2 (3.5) | 2 (7.4) | |
| ORR (95% CI) | 10.6% (5.0-19.2) | 13.8% (6.2-25.4) | 3.7% (0.1-19.0) | 0.304a |
| DCR (95% CI) | 52.9% (41.8-63.9) | 51.7% (38.2-65.1) | 55.6% (35.3-74.5) | 0.742 |
| CBR (95% CI) | 32.9% (23.1-44.0) | 37.9% (25.5-51.6) | 22.2% (8.6-42.3) | 0.15 |
| mPFS, (Months, 95% CI) | 4.5 (3.5-8.3) | 5.7 (3.6-11.7) | 3.6 (3.1-NE) | 0.3 |
| mPPS, (Months, 95% CI) | 14.0 (9.0-18.2) | 14.0 (9.0-21.2) | 15.9 (5.9-NE) | 0.78 |
| mOS, (Months, 95% CI) | 22.1 (19.9-25.9) | 22.1 (17.2-28.6) | 21.3 (19.9-NE) | 0.14 |
CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; NE, not evaluable; ORR, objective response rate; DCR, disease control rate; CBR, clinical benefit rate; PFS, progression-free survival; PPS, post-progression survival; OS, overall survival.
aPearson’s chi-square test using continuity correction.