Table 2.
Summary of response assessed per RECIST v1.1 by independent central review.
| Total population | Overalla N = 107 |
PD-L1+ N = 17 |
PD-L1− N = 83 |
|---|---|---|---|
| ORR,b % (95% CI) | 3.7 (1.0–9.3) | 0 (0.0–19.5) | 4.8 (1.3–11.9) |
| Best overall response, n (%) | |||
| Complete response | 0 | 0 | 0 |
| Partial responsec | 4 (3.7) | 0 | 4 (4.8) |
| Stable disease | 60 (56.1) | 11 (64.7) | 45 (54.2) |
| Progressive disease | 34 (31.8) | 6 (35.3) | 25 (30.1) |
| Nonevaluabled | 5 (4.7) | 0 | 5 (6.0) |
| No assessmente | 4 (3.7) | 0 | 4 (4.8) |
| Patients with response | N = 4 | N = 0 | N = 4 |
| Time to response, months, median (range) | 3.2 (2.1–6.2) | — | 3.2 (2.1–6.2) |
| Responders without subsequent disease progression, n (%) | 1 (25.0) | — | 1 (25.0) |
| Duration of response, months, median (range) | NR (2.2+-27.1+) | — | NR (2.2+-27.1+) |
Abbreviations: CI, confidence interval; NR, not reached; PR, partial response.
a
Includes seven patients with unknown PD-L1 expression level.
b
At the time of analysis, all responses were confirmed.
c
Responses were three pancreatic and one rectal.
d
Patients for whom not all target lesions were captured on ≥1 postbaseline imaging assessment.
e
Patients for whom no postbaseline tumor assessment was performed.