Table 3.
KEYNOTE-048: Pembrolizumab vs. EXTREME according to CPS.
| Nb of Pts | All pts (ITT) | CPS ≥ 1 | CPS ≥ 20 | CPS: 1–19 | CPS < 1 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| P | EXTREME | P | EXTREME | P | EXTREME | P | EXTREME | P | EXTREME | ||
| 301 | 300 | 257 | 255 | 133 | 122 | 124 | 133 | 44 | 45 | ||
| OS | med. | 11.5 | 10.7 | 12.3 | 10.3 | 14.8 | 10.7 | 10.8 | 10.1 | 7.9 | 11.3 |
| HR (95% CI) |
0.83 (0.70–0.99) p = 0.019 |
0.74 (0.61–0.90) p = 0.00133 |
0.58 (0.44–0.78) p = 0.00010 |
0.86 (0.66–1.12) p = 0.1282 |
1.51(0.96–2.37) p = 0.96 |
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| 2-year | 27% | 18.8% | 28.9% | 17.4% | 35.3% | 19.1% | 20.5% | 19.0% | 15.9% | 26.7% | |
| PFS | med. | 2.3 | 5.2 | 3.2 | 5.0 | 3.4 | 5.3 | 2.2 | 4.9 | 2.1 | 6.2 |
| HR (95% CI) |
1.29 (1.09–1.53) p = 0.998 |
1.13 (0.94–1.36) p = 0.895 |
0.99 (0.76–1.29) p = 0.4679 |
1.25 (0.96–1.61) p = 0.95 |
4.31 (2.63–7.08) p = 1.00 |
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| 1-year | 17.6% | 15% | 20.6% | 13.6% | 23.5% | 15.1% | 24.2% § | 41.4% § | 11.4% § | 56% § | |
| RESPONSE | ORR | 16.9% | 36.0% | 19.1% | 34.9% | 23.3% | 36.1% | 14.5% | 33.8% | 4.5% | 42.2% |
| SD | 27.2% | 34.0% | 28.0% | 32.9% | 30.1% | 35.2% | |||||
| PD | 40.5% | 12.3% | 38.9% | 12.9% | 31.6% | 9.8% | |||||
| DOR | 22.6 (1.5–43) | 4.5 (1.2–38.7+) | 23.4 (1.5–43+) | 4.5 (1.2–38.7+) | 22.6 (2.7–43+) | 4.2 (1.2–31.5) | NR (1.5+–38.9+) | 5.0 (1.4+–38.7+) | 2.6 (2.2–3.0) | 7.8 (2.0–38.6+) | |
| ≥6 mo. | 77.8% | 38.8% | 81.1% | 36% | 83.5% | 34.8% | 76.5% | 36.6% | 0% | 52.7% | |
CPS: Combined Positive Score; pts: patients; ITT: Intent To Treat; P: Pembrolizumab; Nb: Number; OS: overall survival; med.: median in months; HR: Hazard Ratio; PFS: Progression Free Survival; §: 6-month PFS; ORR: Overall Response Rate; SD: Stable Disease; PD: Progressive Disease; DOR: Duration Of Response in months (extremes); ≥6 mo: % DOR≥6 mo.