Table 3.
Efficacy in all patients and selected subgroups
| Overall (N=615) |
OAK-like population (n=406) |
Squamous (n=152) | Non-squamous (n=462) | CNS metastases (n=89) |
Renal impairment* (n=78) |
Age ≥75 years (n=76) |
ECOG PS 2 (n=61) |
Prior anti–PD-1 (n=39) |
AID (n=30) |
Active or chronic HBV/HCV (n=15) |
|
| OS events, n | 312 | 181 | 83 | 229 | 58 | 38 | 39 | 46 | 23 | 18 | 8 |
| Median OS, months (95% CI) | 11.1 (8.9 to 12.9) |
13.7 (11.6 to 15.5) |
11.1 (7.9 to 13.7) |
11.0 (8.7 to 13.1) |
5.1 (4.1 to 8.5) |
13.0 (8.5 to 17.0) |
11.3 (7.7 to 17.0) |
3.5 (1.9 to 5.1) |
6.2 (3.5 to 15.0) |
10.1 (6.5 to 14.1) |
14.2 (3.3 to NE) |
| 12-month OS rate, % (95% CI) |
47.8 (43.4 to 52.1) | 54.3 (48.8 to 59.5) | 48.3 (39.2 to 56.8) | 47.5 (42.3 to 52.4) | 26.5 (15.9 to 38.3) | 50.9 (37.7 to 62.6) | 49.7 (36.6 to 61.6) | 22.0 (11.8 to 34.3) | 32.2 (15.6 to 50.2) | 47.8 (27.8 to 65.3) | 56.5 (27.4 to 77.8) |
| Median PFS, months (95% CI) | 2.7 (2.1 to 2.8) | 2.8 (2.7 to 3.9) | 3.0 (2.6 to 4.3) | 2.6 (1.7 to 2.8) | 1.4 (1.3 to 1.5) | 3.1 (2.6 to 5.2) | 4.1 (2.7 to 4.7) | 1.7 (1.4 to 2.8) | 1.6 (1.3 to 2.9) | 2.9 (1.4 to 4.2) | 2.7 (1.3 to 3.4) |
| ORR, % (95% CI) |
11.1 (8.7 to 13.8) | 13.5 (10.4 to 17.3) | 13.2 (8.2 to 19.6) | 10.4 (7.8 to 13.5) | 5.6 (1.8 to 12.6) | 11.5 (5.4 to 20.8) | 11.8 (5.6 to 21.3) | 3.3 (0.4 to 11.3) | 2.6 (0.1 to 13.5) | 10.0 (2.1 to 26.5) | 13.3 (1.7 to 40.5) |
| CR, n (%) | 3 (0.5) | 3 (0.7) | 1 (0.7) | 2 (0.4) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| PR, n (%) | 65 (10.6) | 52 (12.8) | 19 (12.5) | 46 (10.0) | 5 (5.6) | 9 (11.5) | 9 (11.8) | 2 (3.3) | 1 (2.6) | 3 (10.0) | 2 (13.3) |
*Estimated glomerular filtration rate <60 mL/min/1.73 m2.
AID, autoimmune disease; CNS, central nervous system; CR, complete response; ECOG PS, Eastern Cooperative Oncology Group performance status; HBV/HCV, hepatitis B/C virus; NE, not estimable; NE, not estimable; ORR, objective response rate; OS, overall survival; PD-1, programmed death 1; PFS, progression-free survival; PR, partial response.