Safety summary
| Overall (N=615) | OAK-like population (n=406) | 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) | |
| Median treatment duration (min–max), months | 3.2 (0.0–18.6) | 4.5 (0.0–17.9) | 1.4 (0.0–16.3) | 4.0 (0.0–17.4) | 3.9 (0.0–18.6) | 1.4 (0.0–17.4) | 2.1 (0.0–15.4) | 2.8 (0.0–17.4) | 2.0 (0.0–18.6) |
| Any AE, n (%) | 558 (90.7) | 367 (90.4) | 78 (87.6) | 74 (94.9) | 70 (92.1) | 52 (85.2) | 36 (92.3) | 27 (90.0) | 14 (93.3) |
| Grade 3/4 AE, n (%) | 184 (29.9) | 106 (26.1) | 26 (29.2) | 35 (44.9) | 23 (30.3) | 25 (41.0) | 9 (23.1) | 9 (30.0) | 7 (46.7) |
| Grade 5 AE, n (%) | 35 (5.7) | 25 (6.2) | 5 (5.6) | 4 (5.1) | 5 (6.6) | 4 (6.6) | 0 | 1 (3.3) | 1 (6.7) |
| SAE, n (%) | 174 (28.3) | 103 (25.4) | 22 (24.7) | 33 (42.3) | 19 (25.0) | 26 (42.6) | 8 (20.5) | 9 (30.0) | 8 (53.3) |
| Treatment-related AE, n (%) | 330 (53.7) | 223 (54.9) | 41 (46.1) | 55 (70.5) | 42 (55.3) | 30 (49.2) | 12 (30.8) | 21 (70.0) | 11 (73.3) |
| Treatment-related death, n (%) | 9 (1.5) | 6 (1.5) | 3 (3.4) | 1 (1.3) | 0 | 2 (3.3) | 0 | 1 (3.3) | 0 |
| AE leading to drug discontinuation, n (%) | 30 (4.9) | 19 (4.7) | 3 (3.4) | 5 (6.4) | 4 (5.3) | 2 (3.3) | 0 | 5 (16.7) | 0 |
| irAE, n (%) | 59 (9.6) | 40 (9.9) | 5 (5.6) | 13 (16.7) | 8 (10.5) | 6 (9.8) | 3 (7.7) | 4 (13.3) | 1 (6.7) |
*Estimated glomerular filtration rate <60 mL/min/1.73 m2.
AE, adverse event; AID, autoimmune disease; anti–PD-1, anti–programmed death 1; CNS, central nervous system; ECOG PS, Eastern Cooperative Oncology Group performance status; HBV/HCV, hepatitis B/C virus; irAE, immune-related AE; SAE, serious AE.