Table 4.
KEYNOTE-048: Pembrolizumab + Chemotherapy (C) vs. EXTREME according to CPS.
| Nb of Pts | All pts (ITT) | CPS ≥ 1 | CPS ≥ 20 | CPS: 1–19 | CPS < 1 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| P + C | EXTREME | P + C | EXTREME | P + C | EXTREME | P + C | EXTREME | P + C | EXTREME | ||
| 281 | 278 | 242 | 235 | 126 | 110 | 116 | 125 | 39 | 43 | ||
| OS | med. | 13.0 | 10.7 | 13.6 | 10.4 | 14.7 | 11.0 | 12.7 | 9.9 | 11.3 | 10.7 |
| HR (95% CI) |
0.72 (0.60–0.87) p = 0.00025 |
0.65 (0.53–0.80) p = 0.00002 |
0.60 (0.45–0.82) p = 0.00044 |
0.71 (0.54–0.94) p = 0.00726 |
1.21 (0.76–1.94) p = 0.78 |
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| 2-year | 29.4% | 18.2% | 30.8% | 16.8% | 35.4% | 19.4% | 25.9% | 14.5% | 20.5% | 25.6% | |
| PFS | med. | 2.3 | 5.2 | 5.1 | 5.0 | 5.8 | 5.3 | 4.9 | 4.9 | 4.7 | 6.2 |
| HR (95% CI) |
1.29 (1.09–1.53) p = 0.998 |
0.84 (0.69–1.02) p = 0.0369 |
0.76 (0.58–1.01) p = 0.0295 |
0.93 (0.71–1.21) p = 0.29 |
1.46 (0.93–2.30) p = 0.94 |
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| 1-year | 17.6% | 15% | 19.7% | 12.5% | 23.9% | 14.0% | 40.1% § | 40.0% § | 43.6% § | 53.8% § | |
| RESPONSE | ORR | 35.6% | 36.3% | 36.4% | 35.7% | 42.9% | 38.2% | 29.3% | 33.6% | 30.8% | 39.5% |
| SD | 27.8% | 34.2% | 26.4% | 32.8% | 23.0% | 34.5% | |||||
| PD | 17.1% | 11.9% | 17.4% | 12.3% | 15.1% | 8.2% | |||||
| DOR | 6.7 (1.67–39.07) | 4.3 (1.2+–31.5+) | 6.7 (1.6+–39.0+) | 4.5 (1.2–38.7+) | 7.1 (2.1+–39.0+) | 4.2 (1.2+–31.5+) | 5.6 (1.6+–25.6+) | 5.(1.4+–38.7+) | 5.7 (2.6–20.6+) | 4.3 (2.0–31.2+) | |
| ≥6 mo. | 53.5% | 36.8% | 54.3% | 34.3% | 60.2% | 34.0% | 44.3% | 34.0% | 46.9% | 49.0% | |
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.