Table 1.
Updated analysis of clinical outcomes for patients with advanced NSCLC enrolled in the KEYNOTE-001 study.
| Treatment-naïve (n = 101) |
Previously treated (n = 449) |
|
|---|---|---|
| Median OS (95% CI), months | ||
| PD-L1 TPS ⩾ 1% | 22.1 (16.7–27.2) | 11.3 (8.3–14.0) |
| TPS ⩾ 50% | NR (22.1–NR) | 15.4 (10.6–18.5) |
| TPS 1–49% | 19.5 (10.7–22.2) | 8.2 (6.0–12.7) |
| TPS < 1% | 14.7 (3.4–NR) | 8.6 (5.5–12.0) |
| Squamous | 15.6 (6.0–21.0) | 14.7 (10.4–18.4) |
| TPS ⩾ 50% | // | 14.0 (8.0–NR) |
| TPS ⩾ 1% | // | 14.0 (8.3–17.9) |
| TPS < 1% | // | 14.7 (1.2–18.4) |
| Nonsquamous | 26.3 (22.0–NR) | 9.4 (7.3–12.6) |
| TPS ⩾ 50% | // | 15.4 (9.9–18.8) |
| TPS ⩾ 1% | // | 10.5 (7.1–13.7) |
| TPS < 1% | // | 8.6 (5.5–10.6) |
| Current/former smoker | 22.0 (16.7–27.2) | 12.2 (9.2–14.3) |
| TPS ⩾ 50% | // | 15.7 (11.1–NR) |
| TPS ⩾ 1% | // | 13.2 (9.4–15.6) |
| TPS < 1% | // | 8.6 (4.9–13.3) |
| Never smoker | NR (16.2–NR) | 7.6 (5.9–12.1) |
| TPS ⩾ 50% | // | 8.2 (4.9–17.3) |
| TPS ⩾ 1% | // | 7.3 (5.1–13.7) |
| TPS < 1% | // | 9.1 (4.2–21.3) |
| EGFR wildtype | // | 12.1 (9.1–14.3) |
| TPS ⩾ 50% | 15.7 (11.1–NR) | |
| TPS ⩾ 1% | 13.2 (9.2–15.4) | |
| TPS < 1% | 9.1 (5.8–13.6) | |
| EGFR mutant | // | 6.0 (4.6–9.9) |
| TPS ⩾ 50% | 6.5 (2.0–13.7) | |
| TPS ⩾ 1% | 6.5 (4.4–12.6) | |
| TPS < 1% | 5.7 (2.2–NR) | |
| ORR (%) | ||
| TPS ⩾ 50% | 58.3 | 38.3 |
| TPS 1–49% | 17.4 | 12.9 |
| TPS < 1% | 10 | 9.9 |
| Median PFS (95% CI), months | ||
| TPS ⩾ 50% | 12.5 (6.2–NR) | 4.3 (2.3–8.3) |
| TPS 1–49% | 4.2 (3.1–6.4) | 2.4 (2.1–3.4) |
| TPS < 1% | 3.5 (2.1–19.0) | 2.1 (2.0–3.0) |
CI, confidence interval; EGFR, epidermal growth factor receptor; NR, not reached; NSCLC, non-small cell lung cancer; ORR, objective response rate; OS, overall survival; PD-L1, programmed death-ligand 1; PFS, progression-free survival; TPS, tumor proportion score.