Table 1.
Patient demographics and baseline disease characteristics
| Characteristic | Overall study population (N=615) |
| Median age (min–max), year | 64.0 (24–88) |
| Age category (years), n (%) | |
| 18–64 | 308 (50.1) |
| 65–74 | 231 (37.6) |
| ≥75 | 76 (12.4) |
| Male, n (%) | 370 (60.2) |
| Female, n (%) | 245 (39.8) |
| Race, n (%) | |
| White | 483 (78.5) |
| Asian | 76 (12.4) |
| Other | 56 (9.1) |
| Ethnicity, n (%) | |
| Hispanic or Latino | 93 (15.1) |
| Not Hispanic or Latino | 509 (82.8) |
| Not reported | 11 (1.8) |
| Unknown | 2 (0.3) |
| Region, n (%) | |
| EMEA | 455 (74.0) |
| Asia | 70 (11.4) |
| Latin America | 90 (14.6) |
| Smoking status, n (%) | |
| Current/previous | 488 (79.3) |
| Never | 127 (20.7) |
| ECOG PS, n (%) | |
| 0 or 1 | 554 (90.1) |
| 2 | 61 (9.9) |
| Stage IV at diagnosis, n (%) | 581 (94.5) |
| NSCLC histology, n (%)* | |
| Non-squamous | 462 (75.1) |
| Squamous | 152 (24.7) |
| EGFR mutation, n (%) | 40 (6.5) |
| ALK rearrangement, n (%) | 5 (0.8) |
| PD-L1 expression, n (%)† | |
| Positive (≥1%) | 213 (34.6) |
| Negative (<1%) | 168 (27.3) |
| Unknown | 234 (38.1) |
| Prior lines of NSCLC therapy, n (%) | |
| 1 | 398 (64.7) |
| 2 | 177 (28.8) |
| >2 | 40 (6.5) |
| Prior chemotherapy, n (%)‡ | 611 (99.3) |
| Prior anti–PD-1 therapy, n (%) | 39 (6.3) |
| Monotherapy | 33 (5.4) |
| Combined with chemotherapy | 5 (0.8) |
| Combined with anti–CTLA-4 | 1 (0.2) |
| Additional predefined key subgroups | |
| OAK-like population, n (%)§ | 406 (66.0) |
| CNS metastases, n (%) | 89 (14.5) |
| Renal impairment, n (%)¶ | 78 (12.7) |
| History of AID, n (%) | 30 (4.9) |
| Active or chronic HBV/HCV, n (%) | 15 (2.4) |
*One patient had unknown histology.
†PD-L1 expression on tumor cells using central or local testing.
‡Four patients did not receive chemotherapy per protocol requirements.
§Includes patients who would have been eligible for the phase III OAK study per protocol criteria.
¶Defined as an estimated glomerular filtration rate of <60 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration equation.
AID, autoimmune disease; ALK, anaplastic lymphoma kinase; CNS, central nervous system; CTLA, cytotoxic T-lymphocyte-associated protein 4; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; EMEA, Europe, the Middle East, and Africa; HBV/HCV, hepatitis B/C virus; NSCLC, non-small cell lung cancer; PD-1, programmed death 1; PD-L1, programmed death-ligand 1.