TABLE 2.
Antitumor activity per BICR.
| Patients with tumor cell PD‐L1 expression ≥1% | Overall population | |||||
|---|---|---|---|---|---|---|
| Nivolumab plus chemotherapy (n = 158) | Nivolumab plus ipilimumab (n = 158) | Chemotherapy (n = 157) | Nivolumab plus chemotherapy (n = 321) | Nivolumab plus ipilimumab (n = 325) | Chemotherapy (n = 324) | |
| Proportion of patients with objective response | ||||||
| Responders | 83 (53) | 55 (35) | 31 (20) | 152 (47) | 89 (27) | 86 (27) |
| 95% CI | 44–61 | 27–43 | 14–27 | 42–53 | 23–33 | 22–32 |
| Best overall response | ||||||
| Complete response | 27 (17) | 26 (16) | 7 (4) | 47 (15) | 36 (11) | 19 (6) |
| Partial response | 56 (35) | 29 (18) | 24 (15) | 105 (33) | 53 (16) | 67 (21) |
| Stable disease | 40 (25) | 43 (27) | 72 (46) | 102 (32) | 103 (32) | 149 (46) |
| Progressive disease | 23 (15) | 49 (31) | 25 (16) | 43 (13) | 104 (32) | 39 (12) |
| Not evaluable | 12 (8) | 11 (7) | 29 (18) | 24 (7) | 29 (9) | 50 (15) |
| Median time to response, months | 1.5 (1.4–2.8) | 1.5 (1.3–2.8) | 1.5 (1.4–2.8) | 1.5 (1.4–2.6) | 1.5 (1.4–2.8) | 1.5 (1.5–1.7) |
| Median duration of response per BICR, months | 8.4 | 11.8 | 5.7 | 8.2 | 11.1 | 7.1 |
| 95% CI | 6.9–12.4 | 6.8–18.0 | 4.4–8.7 | 6.9–9.7 | 7.1–14.3 | 5.7–8.2 |
| Proportion of patients with duration of response ≥24 months, % | 22 | 36 | 13 | 21 | 29 | 13 |
| 95% CI | 13–33 | 22–49 | 2–33 | 14–29 | 19–40 | 5–25 |
Note: Data are median (IQR) or No. (%) unless otherwise noted.
Abbreviations: BICR, blinded independent central review; PD‐L1, programmed death ligand 1.