Table 3.
Clinical Activity of Durvalumab by PD-L1 Status in Response-Evaluable Patients
| PD-L1 Expression by Location | PD-L1 Status Definition | ORR* | DCR12† | ||
|---|---|---|---|---|---|
| n/N (%) | 95% CI | n/N (%) | 95% CI | ||
| Unselected | 13/42 (31.0) | 17.6 to 47.1 | 20/42 (47.6) | 32.0 to 63.6 | |
| TC or IC | PD-L1–positive (≥ 25% TC or IC) | 13/28 (46.4) | 27.5 to 66.1 | 16/28 (57.1) | 37.2 to 75.5 |
| PD-L1–negative (< 25% TC and IC) | 0/14 (0.0) | 0.0 to 23.2 | 4/14 (28.6) | 8.4 to 58.1 | |
| TC | PD-L1–positive (≥ 25%) | 7/15 (46.7) | 21.3 to 73.4 | 8/15 (53.3) | 26.6 to 78.7 |
| PD-L1–negative (< 25%) | 6/27 (22.2) | 8.6 to 42.3 | 12/27 (44.4) | 25.5 to 64.7 | |
| IC | PD-L1–positive (≥ 25%) | 10/18 (55.6) | 30.8 to 78.5 | 12/18 (66.7) | 41.0 to 86.7 |
| PD-L1–negative (< 25%) | 3/24 (12.5) | 2.7 to 32.4 | 8/24 (33.3) | 15.6 to 55.3 | |
Abbreviations: DCR12, disease control rate at 12 weeks; IC, tumor-infiltrating immune cells; ORR, objective response rate; PD-L1, programmed cell death ligand-1; RECIST, Response Evaluation Criteria in Solid Tumors; TC, tumor cells.
*
ORR was defined as confirmed complete or partial response per RECIST version 1.1.
†
DCR12 was defined as confirmed complete or partial response or stable disease for ≥ 12 weeks per RECIST version 1.1.