Table 3 Updated ESMO-MCBS and ASCO VF scores of Pivotal RCTs of immune-checkpoint inhibitors with updated results
From: Clinical benefit of immune checkpoint inhibitors approved by US Food and Drug Administration
Trial name | Evaluated endpoint | ESMO-MCBS | ASCO VF | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
HR (95% CI) | QOL | Toxicity | Long term benefit | Score | Clinical benefit score | Toxicity score | Tail of the curve | Palliation | QOL | Treatment free interval | NHB | ||
PACIFIC-Updateda | OS | 0.68 (99.73% CI, 0.47–0.997) | Not reported | Not improved | Not qualified | 4 | 32 | −6.2 | 16 | 0 | 0 | 0 | 41.8 |
OAK-Updated | OS | 0.75 (0.64–0.89) | Not improved | Improved | Not qualified | 5 | 25 | 2.7 | 0 | 10 | 0 | 0 | 37.7 |
KEYNOTE-45-Updated | OS | 0.73 (0.59–0.91) | Improved | Improved | Not qualified | 4 | 27 | 1.0 | 20 | 10 | 10 | 68.0 | |
KEYNOTE-24-Updated | OS | 0.60 (0.41–0.89) | Improved | Improved | Not qualified | 5 | 40 | 5.9 | 0 | 10 | 10 | 0 | 65.9 |
KEYNOTE-006-1-Updated | OS | 0.68 (0.53–0.87) | Improved | Not improved | Not qualified | 5 | 32 | 2.3 | 16 | 0 | 10 | 0 | 60.3 |
KEYNOTE-006-2-Updated | OS | 0.68 (0.53–0.86) | Improved | Not improved | Not qualified | 5 | 32 | 3.1 | 16 | 0 | 10 | 0 | 61.1 |
CHECKMATE-141-Updated | OS | 0.68 (0.54–0.86) | Improved | Improved | Not qualified | 5 | 32 | 7.1 | 20 | 10 | 10 | 0 | 79.1 |
CHECKMATE-025-Updateda | OS | 0.73 (98.5% CI, 0.57–0.93) | Improved | Improved | Not qualified | 5 | 27 | 6.8 | 0 | 10 | 10 | 0 | 53.8 |
CHECKMATE-017-Updated | OS | 0.62 (0.48–0.80) | Improved | Improved | Not qualified | 5 | 38 | 11.3 | 20 | 10 | 10 | 0 | 89.3 |
CHECKMATE-057-Updateda | OS | 0.73 (0.62–0.88) | Improved | Improved | Not qualified | 5 | 27 | 8.3 | 20 | 10 | 10 | 0 | 75.3 |
CHECKMATE-066-Updateda | OS | 0.42 (99.79% CI, 0.25–0.73) | Improved | No Improved | Not qualified | 5 | 58 | 2.4 | 16 | 0 | 10 | 0 | 86.4 |
CHECKMATE-067-1-Updateda | OS | 0.54 (0.44–0.67) | Not Improved | Increased | Not qualified | 3 | 46 | −9.0 | 20 | 0 | 0 | 10 | 67.0 |
CHECKMATE-067-2-Updateda | OS | 0.65 (0.53–0.79) | Not Improved | Not improved | Not qualified | 4 | 35 | 0.3 | 20 | 0 | 0 | 0 | 55.3 |
KEYNOTE-002-1-Updated | PFS | 0.57 (0.45–0.73) | Improved | Improved | > 10% improvement in PFS at 1 year but without OS benefit | 4 | 34.4 | 5.4 | 16 | 10 | 10 | 0 | 75.8 |
KEYNOTE-002-2-Updated | PFS | 0.50 (0.39–0.64) | Improved | Improved | > 10% improvement in PFS at 1 year but without OS benefit | 4 | 40 | 4.4 | 16 | 10 | 10 | 0 | 80.4 |
EORTC-18071-Updateda | OS | 0.72 (0.58–0.88) | Not improved | Not improved | Not qualified | A | 28 | −8.5 | 0 | 0 | 0 | 0 | 19.5 |
MDX010–20-1-Updateda | OS | 0.66 (0.51–0.87) | No improved | No improved | Not qualified | 4 | 34 | 1.0 | 20 | 0 | 0 | 0 | 55.0 |
MDX010–20-2-Updateda | OS | 0.68 (0.55–0.85) | No improved | No improved | Not qualified | 4 | 32 | −0.3 | 20 | 0 | 0 | 0 | 51.7 |