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 | ||||
KEYNOTE-189 | OS | 0.49 (0.38–0.64) | Not reported | Not improved | Not qualified | 4 | 51 | −7.5 | 16 | 0 | 0 | 0 | 59.5 | ||
CHECKMATE-214 | OS | 0.63 (99.8%CI, 0.44–0.89 | Improved | Improved | Not qualified | 5 | 37 | 4.9 | 0 | 0 | 10 | 0 | 51.9 | ||
PACIFIC | PFS | 0.52(0.42 to 0.65) | Not reported | Not improved | > 10% improvement in PFS at 1 year | 4 | 38.4 | −6.7 | 16 | 0 | 0 | 0 | 47.7 | ||
OAK | OS | 0.73 (0.62–0.87) | Not reported | Improved | Not qualified | 5 | 27 | 2.7 | 0 | 0 | 0 | 0 | 29.7 | ||
KEYNOTE-45 | OS | 0.73 (0.59–0.91) | Not reported | Improved | Not qualified | 4 | 27 | 1.0 | 20 | 0 | 0 | 0 | 48.0 | ||
KEYNOTE-24 | OS | 0.60 (0.41–0.89) | Not reported | Improved | Not qualified | 5 | 40 | 5.9 | 0 | 0 | 0 | 0 | 45.9 | ||
KEYNOTE-010-1a | OS | 0.61 (0.49–0.75) | Not reported | Improved | Not qualified | 5 | 39 | 5.7 | 20 | 0 | 0 | 0 | 64.7 | ||
KEYNOTE-010-2b | OS | 0.71 (0.58–0.88) | Not reported | Improved | Not qualified | 3 | 29 | 6.6 | 20 | 0 | 0 | 0 | 55.6 | ||
KEYNOTE-006-1c | OS | 0.69 (0.52–0.90) | Not reported | Improved | Not qualified | 5 | 31 | 2.3 | 16 | 0 | 0 | 0 | 49.3 | ||
KEYNOTE-006-2d | OS | 0.63 (0.47–0.83) | Not reported | Improved | Not qualified | 5 | 37 | 3.1 | 16 | 0 | 0 | 0 | 56.1 | ||
CHECKMATE-238 | RFS | 0.65 (0.51–0.83) | Not Improved | Improved | Not qualified | A | 35 | 3.8 | 0 | 0 | 0 | 0 | 38.8 | ||
CHECKMATE-141 | OS | 0.70 (0.52, 0.92) | Improved | Improved | Not qualified | 4 | 30 | 7.1 | 20 | 10 | 10 | 0 | 77.1 | ||
CHECKMATE-025 | OS | 0.73 (98.5% CI, 0.57–0.93) | Improved | Improved | Not qualified | 5 | 27 | 6.8 | 0 | 0 | 10 | 0 | 43.8 | ||
CHECKMATE-017 | OS | 0.59 (0.44–0.79) | Not reported | Improved | Not qualified | 5 | 41 | 11.3 | 20 | 0 | 0 | 0 | 72.3 | ||
CHECKMATE-057 | OS | 0.73 (0.60–0.89) | Not reported | Improved | Not qualified | 5 | 27 | 8.3 | 20 | 0 | 0 | 0 | 55.3 | ||
CHECKMATE-066 | OS | 0.42 (99.79% CI, 0.25–0.73) | Not Improved | Not Improved | Not qualified | 4 | 58 | 2.4 | 16 | 0 | 0 | 0 | 76.4 | ||
CHECKMATE- 067-1e | PFS | 0.42 (99.5% CI, 0.31 to 0.57) | Not reported | Increased toxic death | > 10% improvement in PFS at 1 year | 3 | 46.4 | −5.1 | 16 | 0 | 0 | 0 | 57.3 | ||
CHECKMATE-067-2f | PFS | 0.57 (99.5% CI, 0.43 to 0.76) | Not reported | Improved | > 10% improvement in PFS at 1 year | 4 | 34.4 | 5.5 | 16 | 0 | 0 | 0 | 55.9 | ||
KEYNOTE-002-1g | PFS | 0.57 (0.45–0.73) | Not reported | Improved | > 10% improvement in PFS at 1 year | 4 | 34.4 | 7.3 | 16 | 0 | 0 | 0 | 57.7 | ||
KEYNOTE-002-2h | PFS | 0.50 (0.39–0.64) | Not reported | Improved | > 10% improvement in PFS at 1 year | 4 | 40 | 5.9 | 16 | 0 | 0 | 0 | 61.9 | ||
EORTC-18071 | RFS | 0.75 (0.64–0.90) | Not improved | Not improved | Not qualified | A | 25 | −7.6 | 0 | 0 | 0 | 0 | 17.4 | ||
MDX010–20-1i | OS | 0.66 (0.51–0.87) | Not reported | Not improved | Not qualified | 4 | 34 | 1.0 | 20 | 0 | 0 | 0 | 55.0 | ||
MDX010–20-2j | OS | 0.68 (0.55–0.85) | Not reported | No improved | Not qualified | 4 | 32 | −0.34 | 20 | 0 | 0 | 0 | 51.7 | ||
Trial name | Endpoint | Drug | Cancer | 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 | ||||
KEYNOTE-189* | OS | Pembrolizumab | NSCLC | 0.49 (0.38–0.64) | Not reported | Not improved | Not qualified | 4 | 51 | −7.5 | 16 | 0 | 0 | 0 | 59.5 |
CHECKMATE-214* | OS | Nivolumab | RCC | 0.63 (99.8%CI, 0.44–0.89 | Improved | Improved | Not qualified | 5 | 37 | 4.9 | 0 | 0 | 10 | 0 | 51.9 |
PACIFIC* | PFS | Durvalumab | NSCLC | 0.52(0.42 to 0.65) | Not reported | Not improved | > 10% improvement in PFS at 1 year | 4 | 38.4 | −6.7 | 16 | 0 | 0 | 0 | 47.7 |
OAK | OS | Atezolizumab | NSCLC | 0.73 (0.62–0.87) | Not reported | Improved | Not qualified | 5 | 27 | 2.7 | 0 | 0 | 0 | 0 | 29.7 |
KEYNOTE-45 | OS | Pembrolizumab | UC | 0.73 (0.59–0.91) | Not reported | Improved | Not qualified | 4 | 27 | 1.0 | 20 | 0 | 0 | 0 | 48.0 |
KEYNOTE-24 | OS | Pembrolizumab | NSCLC | 0.60 (0.41–0.89) | Not reported | Improved | Not qualified | 5 | 40 | 5.9 | 0 | 0 | 0 | 0 | 45.9 |
KEYNOTE-010-1a* | OS | Pembrolizumab | NSCLC | 0.61 (0.49–0.75) | Not reported | Improved | Not qualified | 5 | 39 | 5.7 | 20 | 0 | 0 | 0 | 64.7 |
KEYNOTE-010-2b* | OS | Pembrolizumab | NSCLC | 0.71 (0.58–0.88) | Not reported | Improved | Not qualified | 3 | 29 | 6.6 | 20 | 0 | 0 | 0 | 55.6 |
KEYNOTE-006-1c | OS | Pembrolizumab | Melanoma | 0.69 (0.52–0.90) | Not reported | Improved | Not qualified | 5 | 31 | 2.3 | 16 | 0 | 0 | 0 | 49.3 |
KEYNOTE-006-2d | OS | Pembrolizumab | Melanoma | 0.63 (0.47–0.83) | Not reported | Improved | Not qualified | 5 | 37 | 3.1 | 16 | 0 | 0 | 0 | 56.1 |
CHECKMATE-238 | RFS | Nivolumab | Melanoma | 0.65 (0.51–0.83) | Not Improved | Improved | Not qualified | A | 35 | 3.8 | 0 | 0 | 0 | 0 | 38.8 |
CHECKMATE-141 | OS | Nivolumab | SCCHN | 0.70 (0.52, 0.92) | Improved | Improved | Not qualified | 4 | 30 | 7.1 | 20 | 10 | 10 | 0 | 77.1 |
CHECKMATE-025* | OS | Nivolumab | RCC | 0.73 (98.5% CI, 0.57–0.93) | Improved | Improved | Not qualified | 5 | 27 | 6.8 | 0 | 0 | 10 | 0 | 43.8 |
CHECKMATE-017 | OS | Nivolumab | NSCLC | 0.59 (0.44–0.79) | Not reported | Improved | Not qualified | 5 | 41 | 11.3 | 20 | 0 | 0 | 0 | 72.3 |
CHECKMATE-057* | OS | Nivolumab | NSCLC | 0.73 (0.60–0.89) | Not reported | Improved | Not qualified | 5 | 27 | 8.3 | 20 | 0 | 0 | 0 | 55.3 |
CHECKMATE-066* | OS | Nivolumab | RCC | 0.42 (99.79% CI, 0.25–0.73) | Not Improved | Not Improved | Not qualified | 4 | 58 | 2.4 | 16 | 0 | 0 | 0 | 76.4 |
CHECKMATE- 067-1e* | PFS | Nivolumab | Melanoma | 0.42 (99.5% CI, 0.31 to 0.57) | Not reported | Increased toxic death | > 10% improvement in PFS at 1 year | 3 | 46.4 | −5.1 | 16 | 0 | 0 | 0 | 57.3 |
CHECKMATE-067-2f* | PFS | Nivolumab | Melanoma | 0.57 (99.5% CI, 0.43 to 0.76) | Not reported | Improved | > 10% improvement in PFS at 1 year | 4 | 34.4 | 5.5 | 16 | 0 | 0 | 0 | 55.9 |
KEYNOTE-002-1g | PFS | Pembrolizumab | Melanoma | 0.57 (0.45–0.73) | Not reported | Improved | > 10% improvement in PFS at 1 year | 4 | 34.4 | 7.3 | 16 | 0 | 0 | 0 | 57.7 |
KEYNOTE-002-2h | PFS | Pembrolizumab | Melanoma | 0.50 (0.39–0.64) | Not reported | Improved | > 10% improvement in PFS at 1 year | 4 | 40 | 5.9 | 16 | 0 | 0 | 0 | 61.9 |
EORTC-18071* | RFS | Ipilimumab | Melanoma | 0.75 (0.64–0.90) | Not improved | Not improved | Not qualified | A | 25 | −7.6 | 0 | 0 | 0 | 0 | 17.4 |
MDX010–20-1i* | OS | Ipilimumab | Melanoma | 0.66 (0.51–0.87) | Not reported | Not improved | Not qualified | 4 | 34 | 1.0 | 20 | 0 | 0 | 0 | 55.0 |
MDX010–20-2j* | OS | Ipilimumab | Melanoma | 0.68 (0.55–0.85) | Not reported | No improved | Not qualified | 4 | 32 | −0.34 | 20 | 0 | 0 | 0 | 51.7 |