Table 2.
KEYNOTE-010 study: clinical outcomes of pembrolizumab versus docetaxel.
| Total population | Pembro 2 mg/kg n = 345 |
Pembro 10 mg/kg n = 346 |
Docetaxel n = 343 |
|---|---|---|---|
| mOS (95% CI), months | 10.4 (9.4–11.9) | 12.7 (10.0–17.3) | 8.5 (7.5–9.8) |
| HR (95% CI) | 0.71 (0.58–0.88) | 0.61 (0.49–0.75) | – |
| mPFS (95% CI), months | 3.9 (3.1–4.1) | 4.0 (2.7–4.3) | 4.0 (3.1–4.2) |
| HR (95% CI) | 0.88 (0.74–1.05) | 0.79 (0.66–0.94) | – |
| ORR, % (95% CI) | 18 (14.1–22.5) | 18.5 (14.5–23.0) | 9.3 (6.5–12.9) |
| mDOR (range), months | NR (4.2–10.5) | NR (4.2–12.5) | 6 (2.7–6.1) |
| Ongoing response (%) | 80.6 | 75 | 59.4 |
| TPS ⩾ 50% population | Pembro 2 mg/kg n = 139 |
Pembro 10 mg/kg n = 151 |
Docetaxel n = 152 |
| mOS (95% CI), months | 14.9 (10.4–NR) | 17.3 (11.8–NR) | 8.2 (6.4–10.7) |
| HR (95% CI) | 0.54 (0.38–0.77) | 0.50 (0.36–0.70) | – |
| mPFS (95% CI), months | 5.0 (4.0–6.5) | 5.2 (4.1–8.1) | 4.1 (3.6–4.3) |
| HR (95% CI) | 0.59 (0.44–0.78) | 0.59 (0.45–0.78) | – |
| ORR, % (95% CI) | 30.2 (22.7–38.6) | 29.1 (22.0–37.1) | 7.9 (4.1–13.4) |
| mDOR (range), months | NR (4.2–10.4) | NR (4.4–12.6) | 8 (2.6–8.3) |
| Ongoing response (%) | 88.1 | 79.5 | 58.3 |
| TPS 1–49% population | Pembro 2 mg/kg n = 205 |
Pembro 10 mg/kg n = 195 |
Docetaxel n = 191 |
| mOS (95% CI), months | 9.4 (8.7–10.5) | 10.8 (8.9–13.3) | 8.6 (7.8–9.9) |
| HR (95% CI) | 0.79 (0.61–1.04) | 0.71 (0.53–0.94) | – |
| mPFS (95% CI), months | 3.1 (2.1–3.8) | 2.3 (2.1–4.0) | 3.9 (2.5–4.3) |
| HR (95% CI) | 1.07 (0.85–1.34) | 0.99 (0.78–1.25) | – |
| ORR, % (95% CI) | 10 (6.0–15.0) | 10 (6.0–15.0) | 10 (6.0–16.0) |
| mDOR (range), months | 46 (9+ to 87+) | 45 (13+ to 74+) | 26 (6+ to 31) |
| Ongoing response (%) | 65 | 65 | 35 |
CI, confidence interval; HR, hazard ratio; mDOR, median duration of response; mOS, median overall survival; mPFS, median progression-free survival; NR, not reached; ORR, objective response rate; Pembro, pembrolizumab; TPS, tumor proportion score.