Table 1.
Response and disease control in the overall population and patients who survived for 3 years.
| Overall populationa | Patients who survived for 3 yearsa | |||
|---|---|---|---|---|
| Nivolumab (n = 171) | Chemotherapy (n = 158) | Nivolumab (n = 23) | Chemotherapy (n = 8) | |
| BOR, n (%)b | ||||
| CR | 2 (1.2) | 2 (1.3) | 1 (4.3) | 2 (25.0) |
| PR | 31 (18.1) | 32 (20.3) | 8 (34.8) | 4 (50.0) |
| SD | 31 (18.1) | 65 (41.1) | 6 (26.1) | 1 (12.5) |
| PD | 93 (54.4) | 51 (32.3) | 8 (34.8) | 1 (12.5) |
| NE | 14 (8.2) | 8 (5.1) | 0 | 0 |
| ORR, n (%)b [95% CI] | 33 (19.3) [13.7–26.0] | 34 (21.5) [15.4–28.8] | 9 (39.1) [19.7–61.5] | 6 (75.0) [34.9–96.8] |
| DCR, n (%)b [95% CI] | 64 (37.4) [30.2–45.1] | 99 (62.7) [54.6–70.2] | 15 (65.2) [42.7–83.6] | 7 (87.5) [47.3–99.7] |
| Median DOR, months (95% CI) | 6.9 (5.4–11.1) | 3.9 (2.8–4.2) | - | - |
aRandomized patients who had target lesion measurements at baseline.
bPer investigator assessment based on RECIST, v 1.1.