| pembrolizumab vs placebo | recurrence free survival by 43% (fully demonstrated) vitiligo any grade by 196% (harmful effect) suggested Grade 3–5 drug-related AEs by 335% (not demonstrated) suggested progression or death (progression free survival PFS) by 43% (not demonstrated) | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| objective response (ORR) | no data | | Grade 3–5 drug-related AEs | 4.35 [2.53 7.48] | p=0.04 | 0 | 1011 | 1 | KEYNOTE-054, | | recurrence free survival | 0.57 [0.43 0.75] | p=0.04 | 0 | 1019 | 1 | KEYNOTE-054, | | distant metastasis free survival | no data | | death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.57 [0.43 0.75] | p=0.04 | 0 | 1019 | 1 | KEYNOTE-054, | | serious drug-related adverse events | no data | | toxic death | no data | | vitiligo any grade | 2.96 [1.32 6.65] | p=0.04 | 0 | 1011 | 1 | KEYNOTE-054, | | vitiligo grade 3-4 | 0.99 [0.02 49.80] | p=1.00 | 0 | 1011 | 1 | KEYNOTE-054, | | Adverse events leading to treatment discontinuation | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients |
| pembrolizumab (every 2W) vs ipilimumab | No demonstrated result vitiligo any grade by 476% (harmful effect) suggested death (overall survival) by 32% (not demonstrated) suggested progression or death (progression free survival PFS) by 42% (not demonstrated) | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| objective response (ORR) | no data | | Grade 3–5 drug-related AEs | 0.67 [0.42 1.06] | p=1.00 | 0 | 534 | 1 | KEYNOTE-006 (every 2W), | | recurrence free survival | no data | | distant metastasis free survival | no data | | death (overall survival) | 0.68 [0.53 0.87] | p=0.04 | 0 | -18 | 1 | KEYNOTE-006 (every 2W), | | progression or death (progression free survival PFS) | 0.58 [0.46 0.73] | p=0.04 | 0 | -18 | 1 | KEYNOTE-006 (every 2W), | | serious drug-related adverse events | no data | | toxic death | no data | | vitiligo any grade | 5.76 [1.97 16.78] | p=0.04 | 0 | 534 | 1 | KEYNOTE-006 (every 2W), | | vitiligo grade 3-4 | 0.92 [0.02 46.58] | p=1.00 | 0 | 534 | 1 | KEYNOTE-006 (every 2W), | | Adverse events leading to treatment discontinuation | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients |
| pembrolizumab (every 3W) vs ipilimumab | No demonstrated result vitiligo any grade by 616% (harmful effect) suggested Grade 3–5 drug-related AEs by 49% (not demonstrated) suggested death (overall survival) by 32% (not demonstrated) suggested progression or death (progression free survival PFS) by 42% (not demonstrated) | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| objective response (ORR) | no data | | Grade 3–5 drug-related AEs | 0.51 [0.31 0.83] | p=0.04 | 0 | 533 | 1 | KEYNOTE-006 (every 3W), | | recurrence free survival | no data | | distant metastasis free survival | no data | | death (overall survival) | 0.68 [0.53 0.87] | p=0.04 | 0 | 555 | 1 | KEYNOTE-006 (every 3W), | | progression or death (progression free survival PFS) | 0.58 [0.47 0.72] | p=0.04 | 0 | 555 | 1 | KEYNOTE-006 (every 3W), | | serious drug-related adverse events | no data | | toxic death | no data | | vitiligo any grade | 7.16 [2.49 20.59] | p=0.04 | 0 | 533 | 1 | KEYNOTE-006 (every 3W), | | vitiligo grade 3-4 | 0.92 [0.02 46.75] | p=1.00 | 0 | 533 | 1 | KEYNOTE-006 (every 3W), | | Adverse events leading to treatment discontinuation | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients |
| pembrolizumab 10mg/kg vs chemotherapy | No demonstrated result suggested progression or death (progression free survival PFS) by 50% (not demonstrated) | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| objective response (ORR) | no data | | Grade 3–5 drug-related AEs | no data | | recurrence free survival | no data | | distant metastasis free survival | no data | | death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.50 [0.39 0.64] | p=0.04 | 0 | 360 | 1 | KEYNOTE 002 (10mg/kg Q3W), | | serious drug-related adverse events | no data | | toxic death | no data | | vitiligo any grade | 4.30 [0.92 20.19] | p=1.00 | 0 | 350 | 1 | KEYNOTE 002 (10mg/kg Q3W), | | vitiligo grade 3-4 | 0.96 [0.02 48.42] | p=1.00 | 0 | 350 | 1 | KEYNOTE 002 (10mg/kg Q3W), | | Adverse events leading to treatment discontinuation | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients |
| pembrolizumab 2mg/kg vs chemotherapy | No demonstrated result vitiligo any grade by 380% (harmful effect) suggested progression or death (progression free survival PFS) by 43% (not demonstrated) | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| objective response (ORR) | no data | | Grade 3–5 drug-related AEs | no data | | recurrence free survival | no data | | distant metastasis free survival | no data | | death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.57 [0.45 0.73] | p=0.04 | 0 | 359 | 1 | KEYNOTE 002 (2mg/kg Q3W), | | serious drug-related adverse events | no data | | toxic death | no data | | vitiligo any grade | 4.80 [1.04 22.25] | p=0.04 | 0 | 349 | 1 | KEYNOTE 002 (2mg/kg Q3W), | | vitiligo grade 3-4 | 0.96 [0.02 48.69] | p=1.00 | 0 | 349 | 1 | KEYNOTE 002 (2mg/kg Q3W), | | Adverse events leading to treatment discontinuation | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients |
| pembrolizumab 2mg/kg vs pembrolizumab 10mg/kg | No demonstrated result | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| objective response (ORR) | 0.99 [0.48 2.01] | p=1.00 | 0 | 157 | 1 | KEYNOTE-001, | | Grade 3–5 drug-related AEs | 1.75 [0.66 4.63] | p=1.00 | 0 | 173 | 1 | KEYNOTE-001, | | recurrence free survival | no data | | distant metastasis free survival | no data | | death (overall survival) | 1.09 [0.68 1.75] | p=1.00 | 0 | 173 | 1 | KEYNOTE-001, | | progression or death (progression free survival PFS) | 0.84 [0.57 1.23] | p=1.00 | 0 | 173 | 1 | KEYNOTE-001, | | serious drug-related adverse events | 6.61 [0.80 54.90] | p=1.00 | 0 | 173 | 1 | KEYNOTE-001, | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | Adverse events leading to treatment discontinuation | 0.63 [0.21 1.85] | p=1.00 | 0 | 173 | 1 | KEYNOTE-001, |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients |
| pembrolizumab (every 2W) vs ipilimumab | No demonstrated result vitiligo any grade by 476% (harmful effect) suggested death (overall survival) by 32% (not demonstrated) suggested progression or death (progression free survival PFS) by 42% (not demonstrated) | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| objective response (ORR) | no data | | Grade 3–5 drug-related AEs | 0.67 [0.42 1.06] | p=1.00 | 0 | 534 | 1 | KEYNOTE-006 (every 2W), | | recurrence free survival | no data | | distant metastasis free survival | no data | | death (overall survival) | 0.68 [0.53 0.87] | p=0.04 | 0 | -18 | 1 | KEYNOTE-006 (every 2W), | | progression or death (progression free survival PFS) | 0.58 [0.46 0.73] | p=0.04 | 0 | -18 | 1 | KEYNOTE-006 (every 2W), | | serious drug-related adverse events | no data | | toxic death | no data | | vitiligo any grade | 5.76 [1.97 16.78] | p=0.04 | 0 | 534 | 1 | KEYNOTE-006 (every 2W), | | vitiligo grade 3-4 | 0.92 [0.02 46.58] | p=1.00 | 0 | 534 | 1 | KEYNOTE-006 (every 2W), | | Adverse events leading to treatment discontinuation | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients |
| pembrolizumab (every 3W) vs ipilimumab | No demonstrated result vitiligo any grade by 616% (harmful effect) suggested Grade 3–5 drug-related AEs by 49% (not demonstrated) suggested death (overall survival) by 32% (not demonstrated) suggested progression or death (progression free survival PFS) by 42% (not demonstrated) | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| objective response (ORR) | no data | | Grade 3–5 drug-related AEs | 0.51 [0.31 0.83] | p=0.04 | 0 | 533 | 1 | KEYNOTE-006 (every 3W), | | recurrence free survival | no data | | distant metastasis free survival | no data | | death (overall survival) | 0.68 [0.53 0.87] | p=0.04 | 0 | 555 | 1 | KEYNOTE-006 (every 3W), | | progression or death (progression free survival PFS) | 0.58 [0.47 0.72] | p=0.04 | 0 | 555 | 1 | KEYNOTE-006 (every 3W), | | serious drug-related adverse events | no data | | toxic death | no data | | vitiligo any grade | 7.16 [2.49 20.59] | p=0.04 | 0 | 533 | 1 | KEYNOTE-006 (every 3W), | | vitiligo grade 3-4 | 0.92 [0.02 46.75] | p=1.00 | 0 | 533 | 1 | KEYNOTE-006 (every 3W), | | Adverse events leading to treatment discontinuation | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients |
| pembrolizumab 10mg/kg vs chemotherapy | No demonstrated result suggested progression or death (progression free survival PFS) by 50% (not demonstrated) | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| objective response (ORR) | no data | | Grade 3–5 drug-related AEs | no data | | recurrence free survival | no data | | distant metastasis free survival | no data | | death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.50 [0.39 0.64] | p=0.04 | 0 | 360 | 1 | KEYNOTE 002 (10mg/kg Q3W), | | serious drug-related adverse events | no data | | toxic death | no data | | vitiligo any grade | 4.30 [0.92 20.19] | p=1.00 | 0 | 350 | 1 | KEYNOTE 002 (10mg/kg Q3W), | | vitiligo grade 3-4 | 0.96 [0.02 48.42] | p=1.00 | 0 | 350 | 1 | KEYNOTE 002 (10mg/kg Q3W), | | Adverse events leading to treatment discontinuation | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients |
| pembrolizumab 2mg/kg vs chemotherapy | No demonstrated result vitiligo any grade by 380% (harmful effect) suggested progression or death (progression free survival PFS) by 43% (not demonstrated) | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| objective response (ORR) | no data | | Grade 3–5 drug-related AEs | no data | | recurrence free survival | no data | | distant metastasis free survival | no data | | death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.57 [0.45 0.73] | p=0.04 | 0 | 359 | 1 | KEYNOTE 002 (2mg/kg Q3W), | | serious drug-related adverse events | no data | | toxic death | no data | | vitiligo any grade | 4.80 [1.04 22.25] | p=0.04 | 0 | 349 | 1 | KEYNOTE 002 (2mg/kg Q3W), | | vitiligo grade 3-4 | 0.96 [0.02 48.69] | p=1.00 | 0 | 349 | 1 | KEYNOTE 002 (2mg/kg Q3W), | | Adverse events leading to treatment discontinuation | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients |
| pembrolizumab 2mg/kg vs pembrolizumab 10mg/kg | No demonstrated result | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| objective response (ORR) | 0.99 [0.48 2.01] | p=1.00 | 0 | 157 | 1 | KEYNOTE-001, | | Grade 3–5 drug-related AEs | 1.75 [0.66 4.63] | p=1.00 | 0 | 173 | 1 | KEYNOTE-001, | | recurrence free survival | no data | | distant metastasis free survival | no data | | death (overall survival) | 1.09 [0.68 1.75] | p=1.00 | 0 | 173 | 1 | KEYNOTE-001, | | progression or death (progression free survival PFS) | 0.84 [0.57 1.23] | p=1.00 | 0 | 173 | 1 | KEYNOTE-001, | | serious drug-related adverse events | 6.61 [0.80 54.90] | p=1.00 | 0 | 173 | 1 | KEYNOTE-001, | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | Adverse events leading to treatment discontinuation | 0.63 [0.21 1.85] | p=1.00 | 0 | 173 | 1 | KEYNOTE-001, |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients |
