Table 3.
Best overall response by independent assessment, overall, and by PD-L1 CPS status
| First 40 response-evaluable patients |
||
|---|---|---|
| n | ||
| Best overall response,an (%) | ||
| CR | 4 (10.0) | |
| PR | 17 (42.5) | |
| SD | 9 (22.5) | |
| PD | 8 (20.0) | |
| NE | 2 (5.0)b | |
| Objective response (CR + PR), n (%); 95% CI | 40 | 21 (52.5); 36.1-68.5 |
| Disease control (CR + PR + SD ≥3 months), n (%); 95% CI | 40 | 29 (72.5); 56.1-85.4 |
| Duration of response,c months, median (range); 95% CI | 21 | 10.3 (2.10-14.52); 4.57-NE |
| Objective response (CR + PR) in PD-L1 CPS 1-4, n (%); 95% CI | 17 | 9 (52.9); 27.8-77.0 |
| Disease control (CR + PR + SD ≥3 months) in PD-L1 CPS 1-4, n (%); 95% CI | 17 | 11 (64.7); 38.3-85.8 |
| Duration of responsec in PD-L1 CPS 1-4, months, median (range); 95% CI | 9 | 10.3 (4.14-10.25); 4.14-10.25 |
| Objective response (CR + PR) in PD-L1 CPS ≥5, n (%); 95% CI | 23 | 12 (52.2); 30.6-73.2 |
| Disease control (CR + PR + SD ≥3 months) in PD-L1 CPS ≥5, n (%); 95% CI | 23 | 18 (78.3); 56.3-92.5 |
| Duration of responsec in PD-L1 CPS ≥5, months, median (range); 95% CI | 12 | NR (2.10-14.52); 4.57-NE |
| Objective response (CR + PR) in PD-L1 CPS 1-9, n (%); 95% CI | 24 | 12 (50.0); 29.1-70.9 |
| Disease control (CR + PR + SD ≥3 months) in PD-L1 CPS 1-9, n (%); 95% CI | 24 | 17 (70.8); 48.9-87.4 |
| Duration of responsec in PD-L1 CPS 1-9, months, median (range); 95% CI | 12 | 10.3 (2.33-10.25); 4.30-10.25 |
| Objective response (CR + PR) in PD-L1 CPS ≥10, n (%); 95% CI | 16 | 9 (56.3); 29.9-80.2 |
| Disease control (CR + PR + SD ≥3 months) in PD-L1 CPS ≥10, n (%); 95% CI | 16 | 12 (75.0); 47.6-92.7 |
| Duration of responsec in PD-L1 CPS ≥10, months, median (range); 95% CI | 9 | NR (2.10-14.52); 5.32-NE |
Data cut-off 19 July 2021.
CI, confidence interval; CPS, combined positive score; CR, complete response; GC, gastric cancer; NE, not evaluable; NR, not reached; PD, progressive disease; PD-L1, programmed death-ligand 1; PR, partial response; SD, stable disease.
CR and PR include only confirmed responses.
One patient with GC with target lesion not evaluable at post-baseline visit per independent review because of quality of scan imaging and another patient with GC with only baseline scan assessed by independent review (also by investigator) who had clinical progressive disease and discontinued before the first tumor assessment.
Calculated only for patients with objective response of CR or PR.