| treatment |
|
comparator |
death (overall survival) | progression or death (progression free survival PFS) | Adverse events leading to treatment discontinuation | objective response (ORR) | treatment-emergent adverse events (TEAEs) | Grade 3–5 drug-related AEs | Grade 3–5 drug-related AEs | treatment-related deaths | complete response (CR) | serious drug-related adverse events | recurrence free survival | toxic death | vitiligo any grade | vitiligo grade 3-4 | distant metastasis free survival |
|
|
| Ipilimumab | lung cancer (metastatic), in all type of patients | vs placebo + chemotherapy | NS | - | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.91 [0.77 1.07] | p=1.00 | 0 | 749 | 1 | Govindan, | | progression or death (progression free survival PFS) | no data | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| Reck, 2016 | ipilimumab 10 mg/kg plus etoposide and platinum (cisplatin or carboplatin) | placebo plus etoposide and platinum (cisplatin or carboplatin) | patients with newly diagnosed extensive-stage disease SCLC | | Govindan, 2017 | ipilimumab 10 mg/kg + paclitaxel and carboplatin | placebo + paclitaxel and carboplatin | Patients with stage IV or recurrent chemotherapy-naïve squamous NSCLC | | phase 2 (phased ipilimumab), 2012 | concurrent ipilimumab (four doses of ipilimumab plus paclitaxel and carboplatin followed by two doses of placebo plus paclitaxel and carboplatin) or phased ipilimumab (two doses of placebo plus paclitaxel and carboplatin followed by four doses of ipilimum | paclitaxel (175 mg/m(2)) and carboplatin (area under the curve, 6) | Patients with chemotherapy-naive non-small-cell lung cancer |
|
| Ipilimumab | melanoma, in all type of patients | vs dacarbazine | by 28% [demonstrated] | - | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.72 [0.59 0.87] | p=0.04 | 0 | -18 | 1 | Robert, | | progression or death (progression free survival PFS) | no data | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| Robert, 2011 | ipilimumab (10 mg per kilogram) plus dacarbazine (850 mg per square meter of body-surface area) | dacarbazine (850 mg per square meter) | patients with previously untreated metastatic melanoma (stage III (unresectable) orstage IV) |
|
| Ipilimumab | melanoma, in all type of patients | vs gp100 | by 33% | - | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.67 [0.57 0.79] | p=0.04 | 0 | 812 | 2 | Hodi (ipi alone), Hodi (ipi + gp100), | | progression or death (progression free survival PFS) | no data | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| Hodi (ipi alone), 2010 | ipilimumab 3mg/kg every 3 weeks up to 4 treatments | gp100 alone | patients with previously treated metastatic melanoma patients with unresectable stage III or IV melanoma, whose disease had progressed while they were receiving therapy for metastatic disease | | Hodi (ipi + gp100), 2010 | Ipilimumab, at a dose of 3 mg per kilogram of body weight, was administered with gp100 every 3 weeks for up to four treatments | gp100 alone
| patients with previously treated metastatic melanoma patients with unresectable stage III or IV melanoma, whose disease had progressed while they were receiving therapy for metastatic disease
|
|
| Ipilimumab | melanoma, in all type of patients | vs placebo | by 28% | by 24% | - | - | - | by 107% | by 107% | - | - | - | by 24% [demonstrated] | - | - | - | by 24% | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.72 [0.58 0.89] | p=0.04 | 0 | 951 | 1 | EORTC 18071 (Eggermont), | | progression or death (progression free survival PFS) | 0.76 [0.64 0.90] | p=0.04 | 0 | 951 | 1 | EORTC 18071 (Eggermont), | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | 2.07 [1.57 2.72] | p=0.04 | 0 | 945 | 1 | EORTC 18071 (Eggermont), | | Grade 3–5 drug-related AEs | 2.07 [1.57 2.72] | p=0.04 | 0 | 945 | 1 | EORTC 18071 (Eggermont), | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | 0.76 [0.64 0.90] | p=0.04 | 0 | 951 | 1 | EORTC 18071 (Eggermont), | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | 0.76 [0.63 0.91] | p=0.04 | 0 | 951 | 1 | EORTC 18071 (Eggermont), |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| EORTC 18071 (Eggermont), 2015 | ipilimumab at a dose of 10 mg per kilogram every 3 weeks for four doses, then every 3 months for up to 3 years or until disease recurrence or an unacceptable level of toxic effects occurred | placebo | high risk patients who had undergone complete resection of stage III melanoma |
|
| Ipilimumab | melanoma, in second line (or later) | vs gp100 | by 33% | - | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.67 [0.57 0.79] | p=0.04 | 0 | 812 | 2 | Hodi (ipi alone), Hodi (ipi + gp100), | | progression or death (progression free survival PFS) | no data | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| Hodi (ipi alone), 2010 | ipilimumab 3mg/kg every 3 weeks up to 4 treatments | gp100 alone | patients with previously treated metastatic melanoma patients with unresectable stage III or IV melanoma, whose disease had progressed while they were receiving therapy for metastatic disease | | Hodi (ipi + gp100), 2010 | Ipilimumab, at a dose of 3 mg per kilogram of body weight, was administered with gp100 every 3 weeks for up to four treatments | gp100 alone
| patients with previously treated metastatic melanoma patients with unresectable stage III or IV melanoma, whose disease had progressed while they were receiving therapy for metastatic disease
|
|
| Ipilimumab | melanoma, in first line | vs dacarbazine | by 28% [demonstrated] | - | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.72 [0.59 0.87] | p=0.04 | 0 | -18 | 1 | Robert, | | progression or death (progression free survival PFS) | no data | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| Robert, 2011 | ipilimumab (10 mg per kilogram) plus dacarbazine (850 mg per square meter of body-surface area) | dacarbazine (850 mg per square meter) | patients with previously untreated metastatic melanoma (stage III (unresectable) orstage IV) |
|
| Ipilimumab | melanoma, in adjuvant setting | vs placebo | by 28% | by 24% | - | - | - | by 107% | by 107% | - | - | - | by 24% [demonstrated] | - | - | - | by 24% | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.72 [0.58 0.89] | p=0.04 | 0 | 951 | 1 | EORTC 18071 (Eggermont), | | progression or death (progression free survival PFS) | 0.76 [0.64 0.90] | p=0.04 | 0 | 951 | 1 | EORTC 18071 (Eggermont), | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | 2.07 [1.57 2.72] | p=0.04 | 0 | 945 | 1 | EORTC 18071 (Eggermont), | | Grade 3–5 drug-related AEs | 2.07 [1.57 2.72] | p=0.04 | 0 | 945 | 1 | EORTC 18071 (Eggermont), | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | 0.76 [0.64 0.90] | p=0.04 | 0 | 951 | 1 | EORTC 18071 (Eggermont), | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | 0.76 [0.63 0.91] | p=0.04 | 0 | 951 | 1 | EORTC 18071 (Eggermont), |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| EORTC 18071 (Eggermont), 2015 | ipilimumab at a dose of 10 mg per kilogram every 3 weeks for four doses, then every 3 months for up to 3 years or until disease recurrence or an unacceptable level of toxic effects occurred | placebo | high risk patients who had undergone complete resection of stage III melanoma |
|
| Nivolumab | gastric or gastro-oesophageal junction cancer (advanced), in all type of patients | vs placebo | by 37% | - | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.63 [0.51 0.78] | p=0.04 | 0 | 493 | 1 | ATTRACTION-2, | | progression or death (progression free survival PFS) | no data | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| ATTRACTION-2, 2017 | nivolumab at 3 mg/kg every 2 weeks | placebo | patients with advanced gastric or gastro-oesophageal
junction cancer who had been previously been treated with two or more chemotherapy regimens |
|
| Nivolumab | Head and neck cancer, in all type of patients | vs standard treatment | by 30% [demonstrated] | NS | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.70 [0.51 0.96] | p=0.04 | 0 | 361 | 1 | Checkmate-141, | | progression or death (progression free survival PFS) | 0.89 [0.70 1.13] | p=1.00 | 0 | 361 | 1 | Checkmate-141, | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| Checkmate-141, 2016 | nivolumab (at a dose of 3 mg per kilogram of body weight) every 2 weeks | standard, single-agent systemic therapy (methotrexate, docetaxel, or cetuximab). | patients with recurrent squamous-cell carcinoma of the head and neck whose disease had progressed within 6 months after platinum-based chemotherapy |
|
| Nivolumab | lung cancer (metastatic), in all type of patients | vs docetaxel | by 32% | by 18% | - | by 128% | - | by 83% | by 83% | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.68 [0.57 0.81] | p=0.04 | 0 | 854 | 2 | CheckMate 057, CheckMate 017, | | progression or death (progression free survival PFS) | 0.82 [0.70 0.95] | p=0.04 | 0 | 854 | 2 | CheckMate 057, CheckMate 017, | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | 2.28 [1.10 4.72] | p=0.04 | 0 | 272 | 1 | CheckMate 017, | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | 0.17 [0.12 0.26] | p=0.04 | 0 | 815 | 2 | CheckMate 057, CheckMate 017, | | Grade 3–5 drug-related AEs | 0.17 [0.12 0.26] | p=0.04 | 0 | 815 | 2 | CheckMate 057, CheckMate 017, | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| CheckMate 057, 2015 | Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression | Docetaxel 75 mg/m² concentrate for solution for intravenous infusion every 3 weeks until documented disease progression | patients with advanced nonsquamous nonsmall cell lung cancer (NSCLC) who had progressed on platinum-doublet chemotherapy | | CheckMate 017, 2015 | Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression | Docetaxel 75 mg/m2 solution intravenously every 3 weeks until documented disease progression | patients with advanced SQ NSCLC who fail platinum-based doublet chemotherapy |
|
| Nivolumab | lung cancer (metastatic), in all type of patients | vs platinum-based CT | NS | by 15% | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 1.02 [0.80 1.30] | p=1.00 | 0 | 541 | 1 | CheckMate 026, | | progression or death (progression free survival PFS) | 0.85 [0.73 0.99] | p=0.04 | 0 | 1203 | 3 | CheckMate 026, CheckMate 227 (High Tumor Mutational Burden), CheckMate 227 (nivolumab + CT), | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| CheckMate 026, 2016 | Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression | platinum-based chemotherapy (administered once every 3 weeks for up to six cycles). | patients with previously untreated advanced non-small cell lung cancer (NSCLC) whose tumors expressed PD-L1 at >5% (>1%???). Patients with EGFR activating mutations and ALK translocations, which are sensitive to targeted therapy, were excluded.
| | CheckMate 227 (High Tumor Mutational Burden), 2018 | nivolumab plus ipilimumab | chemotherapy | patients with stage IV or recurrent NSCLC that was not previously treated
with chemotherapy and high tumor mutational burden (>=10 mutations
per megabase), irrespective of PD-L1 expression level | | CheckMate 227 (nivolumab + CT), 2018 | Nivolumab + chemotherapy | chemotherapy | Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer <1% tumor PD-L1 expression
|
|
| Nivolumab | lung cancer (metastatic), in second line | vs docetaxel | by 32% | by 18% | - | by 128% | - | by 83% | by 83% | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.68 [0.57 0.81] | p=0.04 | 0 | 854 | 2 | CheckMate 057, CheckMate 017, | | progression or death (progression free survival PFS) | 0.82 [0.70 0.95] | p=0.04 | 0 | 854 | 2 | CheckMate 057, CheckMate 017, | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | 2.28 [1.10 4.72] | p=0.04 | 0 | 272 | 1 | CheckMate 017, | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | 0.17 [0.12 0.26] | p=0.04 | 0 | 815 | 2 | CheckMate 057, CheckMate 017, | | Grade 3–5 drug-related AEs | 0.17 [0.12 0.26] | p=0.04 | 0 | 815 | 2 | CheckMate 057, CheckMate 017, | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| CheckMate 057, 2015 | Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression | Docetaxel 75 mg/m² concentrate for solution for intravenous infusion every 3 weeks until documented disease progression | patients with advanced nonsquamous nonsmall cell lung cancer (NSCLC) who had progressed on platinum-doublet chemotherapy | | CheckMate 017, 2015 | Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression | Docetaxel 75 mg/m2 solution intravenously every 3 weeks until documented disease progression | patients with advanced SQ NSCLC who fail platinum-based doublet chemotherapy |
|
| Nivolumab | lung cancer (metastatic), in first line | vs platinum-based CT | NS | by 15% | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 1.02 [0.80 1.30] | p=1.00 | 0 | 541 | 1 | CheckMate 026, | | progression or death (progression free survival PFS) | 0.85 [0.73 0.99] | p=0.04 | 0 | 1203 | 3 | CheckMate 026, CheckMate 227 (High Tumor Mutational Burden), CheckMate 227 (nivolumab + CT), | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| CheckMate 026, 2016 | Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression | platinum-based chemotherapy (administered once every 3 weeks for up to six cycles). | patients with previously untreated advanced non-small cell lung cancer (NSCLC) whose tumors expressed PD-L1 at >5% (>1%???). Patients with EGFR activating mutations and ALK translocations, which are sensitive to targeted therapy, were excluded.
| | CheckMate 227 (High Tumor Mutational Burden), 2018 | nivolumab plus ipilimumab | chemotherapy | patients with stage IV or recurrent NSCLC that was not previously treated
with chemotherapy and high tumor mutational burden (>=10 mutations
per megabase), irrespective of PD-L1 expression level | | CheckMate 227 (nivolumab + CT), 2018 | Nivolumab + chemotherapy | chemotherapy | Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer <1% tumor PD-L1 expression
|
|
| Nivolumab | melanoma, in all type of patients | vs nivolumab | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| CheckMate 067 (nivo + ipi vs nivo), 2015 | Nivolumab + ipilumab
| nivolumab alone
| Previously Untreated Advanced Melanoma
|
|
| Nivolumab | melanoma, in all type of patients | vs chemotherapy | - | - | - | by 272% | - | by 71% | by 71% | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | 3.72 [1.25 11.12] | p=0.04 | 0 | 167 | 1 | CheckMate 037 (Weber), | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | 0.29 [0.16 0.52] | p=0.04 | 0 | 370 | 1 | CheckMate 037 (Weber), | | Grade 3–5 drug-related AEs | 0.29 [0.16 0.52] | p=0.04 | 0 | 370 | 1 | CheckMate 037 (Weber), | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| CheckMate 037 (Weber), 2015 | ntravenous infusion of nivolumab 3 mg/kg every 2
weeks until progression or unacceptable toxic eff ects | investigator’s choice of chemotherapy (dacarbazine 1000 mg/m² every 3 weeks or paclitaxel 175 mg/m² combined with carboplatin area under the
curve 6 every 3 weeks) | patients with advanced
melanoma who progressed after ipilimumab, or
ipilimumab and a BRAF inhibitor if they were BRAFV mutation-positive (second-line or later-line treatment) |
|
| Nivolumab | melanoma, in all type of patients | vs dacarbazine | by 58% [demonstrated] | by 57% | NS | - | - | NS | NS | - | - | - | - | - | by 2089% | NS | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.42 [0.25 0.71] | p=0.04 | 0 | 418 | 1 | CheckMate 066 (Robert), | | progression or death (progression free survival PFS) | 0.43 [0.34 0.55] | p=0.04 | 0 | 418 | 1 | CheckMate 066 (Robert), | | Adverse events leading to treatment discontinuation | 0.58 [0.29 1.16] | p=1.00 | 0 | 411 | 1 | CheckMate 066 (Robert), | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | 0.66 [0.38 1.16] | p=1.00 | 0 | 411 | 1 | CheckMate 066 (Robert), | | Grade 3–5 drug-related AEs | 0.66 [0.38 1.16] | p=1.00 | 0 | 411 | 1 | CheckMate 066 (Robert), | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | 21.89 [2.92 164.04] | p=0.04 | 0 | 411 | 1 | CheckMate 066 (Robert), | | vitiligo grade 3-4 | 1.00 [0.02 50.40] | p=1.00 | 0 | 411 | 1 | CheckMate 066 (Robert), | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| CheckMate 066 (Robert), 2015 | nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks | dacarbazine at a dose of 1000 mg per square meter of body-surface area every 3 weeks | previously untreated patients who had unresectable metastatic melanoma without a BRAF mutation (stage III or IV) |
|
| Nivolumab | melanoma, in all type of patients | vs ipilimumab | - | by 45% [demonstrated] | by 35% | - | - | by 28% | by 28% | - | - | - | by 35% [demonstrated] | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.55 [0.47 0.65] | p=0.04 | 0 | 2166 | 3 | CheckMate 067 (nivo + ipi vs ipi), CheckMate 238, CheckMate 067 (nivo vs ipi), | | Adverse events leading to treatment discontinuation | 0.65 [0.51 0.82] | p=0.04 | 0 | 2154 | 3 | CheckMate 067 (nivo + ipi vs ipi), CheckMate 238, CheckMate 067 (nivo vs ipi), | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | 0.72 [0.59 0.87] | p=0.04 | 0 | 2153 | 3 | CheckMate 067 (nivo + ipi vs ipi), CheckMate 238, CheckMate 067 (nivo vs ipi), | | Grade 3–5 drug-related AEs | 0.72 [0.59 0.87] | p=0.04 | 0 | 2153 | 3 | CheckMate 067 (nivo + ipi vs ipi), CheckMate 238, CheckMate 067 (nivo vs ipi), | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | 0.65 [0.51 0.83] | p=0.04 | 0 | 906 | 1 | CheckMate 238, | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| CheckMate 067 (nivo + ipi vs ipi), 2015 | 1mg of nivolumab per kilogram every 3 weeks plus 3 mg
of ipilimumab per kilogram every 3 weeks for
4 doses, followed by 3 mg of nivolumab per kilogram every 2 weeks for cycle 3 and beyond | 3 mg of ipilimumab per kilogram every 3 weeks
for 4 doses | Previously Untreated Advanced Melanoma | | CheckMate 238, 2017 | nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks | ipilimumab at a dose of 10 mg per kilogram every 3 weeks for four doses and then every 12 weeks | patients with Complete Resection of Stage IIIb/c or Stage IV Melanoma | | Postow, 2015 | nivolumab (1 mg per kilogram)and ipilimumab (3 mg per kilogram of body weight) combined once every 3 weeks for four doses followed
by nivolumab (3 mg per kilogram) every 2 weeks until the occurrence
of disease progression or unacceptable toxic effects | | patients with metastatic melanoma who
had not previously received treatment, | | CheckMate 067 (nivo vs ipi), 2015 | 3 mg
of nivolumab per kilogram of body weight every
2 weeks
| 3 mg of ipilimumab per kilogram every 3 weeks
for 4 doses | Previously Untreated Advanced Melanoma
|
|
| Nivolumab | melanoma, in first line | vs nivolumab | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| CheckMate 067 (nivo + ipi vs nivo), 2015 | Nivolumab + ipilumab
| nivolumab alone
| Previously Untreated Advanced Melanoma
|
|
| Nivolumab | melanoma, in first line | vs dacarbazine | by 58% [demonstrated] | by 57% | NS | - | - | NS | NS | - | - | - | - | - | by 2089% | NS | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.42 [0.25 0.71] | p=0.04 | 0 | 418 | 1 | CheckMate 066 (Robert), | | progression or death (progression free survival PFS) | 0.43 [0.34 0.55] | p=0.04 | 0 | 418 | 1 | CheckMate 066 (Robert), | | Adverse events leading to treatment discontinuation | 0.58 [0.29 1.16] | p=1.00 | 0 | 411 | 1 | CheckMate 066 (Robert), | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | 0.66 [0.38 1.16] | p=1.00 | 0 | 411 | 1 | CheckMate 066 (Robert), | | Grade 3–5 drug-related AEs | 0.66 [0.38 1.16] | p=1.00 | 0 | 411 | 1 | CheckMate 066 (Robert), | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | 21.89 [2.92 164.04] | p=0.04 | 0 | 411 | 1 | CheckMate 066 (Robert), | | vitiligo grade 3-4 | 1.00 [0.02 50.40] | p=1.00 | 0 | 411 | 1 | CheckMate 066 (Robert), | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| CheckMate 066 (Robert), 2015 | nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks | dacarbazine at a dose of 1000 mg per square meter of body-surface area every 3 weeks | previously untreated patients who had unresectable metastatic melanoma without a BRAF mutation (stage III or IV) |
|
| Nivolumab | melanoma, in first line | vs ipilimumab | - | by 51% [demonstrated] | by 41% | - | - | NS | NS | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.49 [0.40 0.61] | p=0.04 | 0 | 1260 | 2 | CheckMate 067 (nivo + ipi vs ipi), CheckMate 067 (nivo vs ipi), | | Adverse events leading to treatment discontinuation | 1.41 [1.03 1.93] | p=0.04 | 0 | 1248 | 2 | CheckMate 067 (nivo + ipi vs ipi), CheckMate 067 (nivo vs ipi), | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | 1.20 [0.93 1.55] | p=1.00 | 0 | 1248 | 2 | CheckMate 067 (nivo + ipi vs ipi), CheckMate 067 (nivo vs ipi), | | Grade 3–5 drug-related AEs | 1.20 [0.93 1.55] | p=1.00 | 0 | 1248 | 2 | CheckMate 067 (nivo + ipi vs ipi), CheckMate 067 (nivo vs ipi), | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| CheckMate 067 (nivo + ipi vs ipi), 2015 | 1mg of nivolumab per kilogram every 3 weeks plus 3 mg
of ipilimumab per kilogram every 3 weeks for
4 doses, followed by 3 mg of nivolumab per kilogram every 2 weeks for cycle 3 and beyond | 3 mg of ipilimumab per kilogram every 3 weeks
for 4 doses | Previously Untreated Advanced Melanoma | | CheckMate 067 (nivo vs ipi), 2015 | 3 mg
of nivolumab per kilogram of body weight every
2 weeks
| 3 mg of ipilimumab per kilogram every 3 weeks
for 4 doses | Previously Untreated Advanced Melanoma
|
|
| Nivolumab | melanoma, in second line (or later) | vs chemotherapy | - | - | - | by 272% | - | by 71% | by 71% | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | 3.72 [1.25 11.12] | p=0.04 | 0 | 167 | 1 | CheckMate 037 (Weber), | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | 0.29 [0.16 0.52] | p=0.04 | 0 | 370 | 1 | CheckMate 037 (Weber), | | Grade 3–5 drug-related AEs | 0.29 [0.16 0.52] | p=0.04 | 0 | 370 | 1 | CheckMate 037 (Weber), | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| CheckMate 037 (Weber), 2015 | ntravenous infusion of nivolumab 3 mg/kg every 2
weeks until progression or unacceptable toxic eff ects | investigator’s choice of chemotherapy (dacarbazine 1000 mg/m² every 3 weeks or paclitaxel 175 mg/m² combined with carboplatin area under the
curve 6 every 3 weeks) | patients with advanced
melanoma who progressed after ipilimumab, or
ipilimumab and a BRAF inhibitor if they were BRAFV mutation-positive (second-line or later-line treatment) |
|
| Nivolumab | melanoma, in adjuvant setting | vs ipilimumab | - | by 35% | by 77% | - | - | by 69% | by 69% | - | - | - | by 35% [demonstrated] | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.65 [0.51 0.83] | p=0.04 | 0 | 906 | 1 | CheckMate 238, | | Adverse events leading to treatment discontinuation | 0.23 [0.16 0.33] | p=0.04 | 0 | 906 | 1 | CheckMate 238, | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | 0.31 [0.23 0.43] | p=0.04 | 0 | 905 | 1 | CheckMate 238, | | Grade 3–5 drug-related AEs | 0.31 [0.23 0.43] | p=0.04 | 0 | 905 | 1 | CheckMate 238, | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | 0.65 [0.51 0.83] | p=0.04 | 0 | 906 | 1 | CheckMate 238, | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| CheckMate 238, 2017 | nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks | ipilimumab at a dose of 10 mg per kilogram every 3 weeks for four doses and then every 12 weeks | patients with Complete Resection of Stage IIIb/c or Stage IV Melanoma |
|
| Nivolumab | renal-cell carcinoma (advanced), in all type of patients | vs everolimus | by 27% | NS | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.73 [0.57 0.93] | p=0.04 | 0 | -18 | 1 | Chekmate 025 (Motzer), | | progression or death (progression free survival PFS) | 0.88 [0.75 1.03] | p=1.00 | 0 | -18 | 1 | Chekmate 025 (Motzer), | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| Chekmate 025 (Motzer), 2015 | 3 mg of nivolumab per kilogram of body weight intravenously every 2 weeks | 10-mg everolimus tablet orally once daily | patients with advanced clear-cell renal-cell carcinoma for which they had received previous treatment with one or two regimens of antiangiogenic therapy |
|
| Nivolumab | renal-cell carcinoma (advanced), in all type of patients | vs sunitinib | by 32% [demonstrated] | NS | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.68 [0.49 0.95] | p=0.04 | 0 | -18 | 1 | CheckMate-214, | | progression or death (progression free survival PFS) | 0.82 [0.64 1.05] | p=1.00 | 0 | -18 | 1 | CheckMate-214, | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| CheckMate-214, 2017 | nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks for 4 doses followed by Opdivo 3 mg/kg every 2 weeks | sunitinib 50 mg once daily for 4 weeks, followed by 2 weeks off before continuation of treatment | intermediate and poor-risk patients previously untreated advanced or metastatic renal cell carcinoma |
|
| Nivolumab | urothelial carcinoma (advanced), in all type of patients | vs nil | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| Checkmate 275, | nivolumab 3 mg/kg intravenously every 2 weeks until disease progression and clinical deterioration, unacceptable toxicity, or other protocol-defined reasons | | patients with metastatic urothelial carcinoma after platinum therapy |
|
| Atezolizumab | lung cancer (metastatic), in all type of patients | vs bevacizumab (on top platinum-based CT) | - | by 41% | - | NS | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.59 [0.51 0.68] | p=0.04 | 0 | 1492 | 2 | IMpower150 (WT), IMpower150 (Teff), | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | 1.01 [0.31 3.22] | p=1.00 | 0 | 976 | 2 | IMpower150 (WT), IMpower150 (Teff), | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| IMpower150 (WT), 2018 | atezo + bev + C + P; | bev + C + P | wild type chemotherapy-naïve patients with Stage IV non-squamous non-small cell lung cancer (EGFR et ALK negative) | | IMpower150 (Teff), 2018 | atezo + bev + C + P
| bev + C + P
| chemotherapy-naïve patients with Stage IV non-squamous non-small cell lung cancer and expression of a tumour T-effector gene signature (Teff) and EGFR et ALK negative (wild type) |
|
| Atezolizumab | lung cancer (metastatic), in all type of patients | vs docetaxel | by 27% | NS | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.73 [0.63 0.84] | p=0.04 | 0 | 1512 | 2 | POPLAR Phase 2 atezolizumab, OAK, | | progression or death (progression free survival PFS) | 0.95 [0.82 1.10] | p=1.00 | 0 | 1225 | 1 | OAK, | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| POPLAR Phase 2 atezolizumab, 2016 | Atezolizumab | docetaxel 75 mg/m(2) once every 3 weeks | patients with locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Th | | OAK, 2016 | atelozumab | docetaxel | Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy |
|
| Atezolizumab | lung cancer (metastatic), in second line | vs docetaxel | by 27% | NS | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.73 [0.63 0.84] | p=0.04 | 0 | 1512 | 2 | POPLAR Phase 2 atezolizumab, OAK, | | progression or death (progression free survival PFS) | 0.95 [0.82 1.10] | p=1.00 | 0 | 1225 | 1 | OAK, | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| POPLAR Phase 2 atezolizumab, 2016 | Atezolizumab | docetaxel 75 mg/m(2) once every 3 weeks | patients with locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Th | | OAK, 2016 | atelozumab | docetaxel | Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy |
|
| Atezolizumab | lung cancer (metastatic), in first line | vs bevacizumab (on top platinum-based CT) | - | by 41% | - | NS | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.59 [0.51 0.68] | p=0.04 | 0 | 1492 | 2 | IMpower150 (WT), IMpower150 (Teff), | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | 1.01 [0.31 3.22] | p=1.00 | 0 | 976 | 2 | IMpower150 (WT), IMpower150 (Teff), | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| IMpower150 (WT), 2018 | atezo + bev + C + P; | bev + C + P | wild type chemotherapy-naïve patients with Stage IV non-squamous non-small cell lung cancer (EGFR et ALK negative) | | IMpower150 (Teff), 2018 | atezo + bev + C + P
| bev + C + P
| chemotherapy-naïve patients with Stage IV non-squamous non-small cell lung cancer and expression of a tumour T-effector gene signature (Teff) and EGFR et ALK negative (wild type) |
|
| Atezolizumab | urothelial carcinoma (advanced), in all type of patients | vs nil | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| IMvigor210, | Atezolizumab | single arm study | Cohort 1 will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. Cohort 2 will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen |
|
| Atezolizumab | urothelial carcinoma (advanced), in all type of patients | vs chemotherapy | NS | - | - | NS | - | by 54% | by 54% | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.87 [0.63 1.21] | p=1.00 | 0 | 234 | 1 | IMvigor211 (IC2/3), | | progression or death (progression free survival PFS) | no data | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | 1.07 [0.57 1.99] | p=1.00 | 0 | 229 | 1 | IMvigor211 (IC2/3), | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | 0.46 [0.35 0.63] | p=0.04 | 0 | 902 | 1 | IMvigor211 (IC2/3), | | Grade 3–5 drug-related AEs | 0.46 [0.35 0.63] | p=0.04 | 0 | 902 | 1 | IMvigor211 (IC2/3), | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| IMvigor211 (IC2/3), | atezolizumab | chemotherapy | patients with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen |
|
| Atezolizumab | urothelial carcinoma (advanced), in all type of patients | vs control | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| IMVIGOR-130 (monotherapy), 0 | Atezolizumab+Gemcitabine+Carboplatin/Cisplatin | Placebo+Gemcitabine+Carboplatin/Cisplatin | Patients With Untreated Locally Advanced or Metastatic Urothelial Carcinoma |
|
| Durvalumab | lung cancer (metastatic), in all type of patients | vs Standard of Care | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| ARCTIC PD-L1 negative, 2018 | combination of MEDI4736 (durvalumab) plus tremelimumab | Standard of Care
| patients with PD-L1 negative Locally Advanced or Metastatic Non Small Cell Lung Cancer who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC
|
|
| Durvalumab | lung cancer (metastatic), in all type of patients | vs placebo | - | by 48% [demonstrated] | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.52 [0.42 0.65] | p=0.04 | 0 | 709 | 1 | PACIFIC, | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| PACIFIC, 2017 | Durvalumab (at a dose of 10 mg per kilogram of body weight intravenously) every 2 weeks for up to 12 months, administered 1 to 42 days after the patients had received chemoradiotherapy | placebo | patients with stage III NSCLC who did not have disease progression after two or more cycles of platinum-based chemoradiotherapy |
|
| Durvalumab | lung cancer (metastatic), in second line | vs Standard of Care | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| ARCTIC PD-L1 negative, 2018 | combination of MEDI4736 (durvalumab) plus tremelimumab | Standard of Care
| patients with PD-L1 negative Locally Advanced or Metastatic Non Small Cell Lung Cancer who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC
|
|
| Durvalumab | urothelial carcinoma (advanced), in all type of patients | vs nil | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| durvalumab phase 1/2, | durvalumab at 10 mg/kg body weight administered as an intravenous infusion over 60 minutes every two weeks until disease progression or unacceptable toxicity | | patients with locally-advanced or metastatic urothelial carcinoma of the bladder who had progressed while on or after a platinum-containing chemotherapy, including those who progressed within 12 months of receiving therapy in a neoadjuvant or adjuvant setting |
|
| Pembrolizumab | gastric or gastro-oesophageal junction cancer (advanced), in all type of patients | vs nil | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| KEYNOTE-059, | | | |
|
| Pembrolizumab | gastric or gastro-oesophageal junction cancer (advanced), in all type of patients | vs paclitaxel | NS | by 27% | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.82 [0.66 1.02] | p=1.00 | 0 | -18 | 1 | Keynote 061, | | progression or death (progression free survival PFS) | 1.27 [1.03 1.57] | p=0.04 | 0 | -18 | 1 | Keynote 061, | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| Keynote 061, 2018 | pembrolizumab | paclitaxel | patients with advanced gastric or gastro-oesophageal junction cancer that progressed on first-line chemotherapy with a platinum and fluoropyrimidine and who had a PD-L1 CPS of 1 or higher |
|
| Pembrolizumab | Head and neck cancer, in all type of patients | vs standard treatment | by 19% | - | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.81 [0.66 0.99] | p=0.04 | 0 | -18 | 1 | KEYNOTE-040, | | progression or death (progression free survival PFS) | no data | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| KEYNOTE-040, | pembrolizumab 200 mg intravenous (IV) on Day 1 of each 3-week cycle | standard treatment (methotrexate, docetaxel or cetuximab) | patients with recurrent or metastatic head and neck squamous cell cancer |
|
| Pembrolizumab | lung cancer (metastatic), in all type of patients | vs docetaxel | by 34% | by 17% | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.66 [0.57 0.76] | p=0.04 | 0 | 1377 | 2 | Keynote 010 2mg, Keynote 010 10mg, | | progression or death (progression free survival PFS) | 0.83 [0.74 0.94] | p=0.04 | 0 | 1377 | 2 | Keynote 010 2mg, Keynote 010 10mg, | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| Keynote 010 2mg, 2015 | pembrolizumab
2 mg/kg | docetaxel 75 mg/m² every 3 weeks | patients
with previously treated non-small-cell lung cancer with PD-L1 expression on at least 1% of tumour cells | | Keynote 010 10mg, 2015 | pembrolizumab
10 mg/kg
| docetaxel 75 mg/m² every 3 weeks
| patients
with previously treated non-small-cell lung cancer with PD-L1 expression on at least 1% of tumour cells |
|
| Pembrolizumab | lung cancer (metastatic), in all type of patients | vs platinum-based CT | by 29% [demonstrated] | by 48% [demonstrated] | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.71 [0.65 0.77] | p=0.04 | 0 | 3778 | 7 | Keynote 042 (>=1%), Keynote 024, KEYNOTE-021 phase 2, Keynote 189, Keynote 407, Keynote 042 (>=50%), Keynote 042 (>=20%), | | progression or death (progression free survival PFS) | 0.52 [0.44 0.60] | p=0.04 | 0 | 1044 | 3 | Keynote 024, KEYNOTE-021 phase 2, Keynote 189, | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| Keynote 042 (>=1%), 2018 | pembrolizumab 200 mg every 3 wk for 35 cycles or until disease progression, intolerable toxicity | investigators choice of carboplatin plus paclitaxel or carboplatin plus pemetrexed for a maximum of 6 cycles | Treatment Naïve Subjects With PD-L1 Positive Advanced or Metastatic Non-Small Cell Lung Cancer | | Keynote 024, 2015 | Pembrolizumab (200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD
| standard of care (SOC) platinum-based chemotherapies
| previously
untreated advanced NSCLC with PD-L1 expression on at least 50% of tumor cells
and no sensitizing mutation of the epidermal growth factor receptor gene or translocation
of the anaplastic lymphoma kinase gene | | KEYNOTE-021 phase 2, 2016 | 24 months treatment with pembrolizumab (200mg every three weeks)+ CT | four cycles of carboplatin and pemetrexed (500 mg/m2 every three weeks) | patients with stage IIIB/IV, chemotherapy-naive, nonsquamous non-small-cell lung cancer | | Keynote 189, 2018 | pemetrexed
and a platinum-based drug plus 200 mg of pembrolizumab, followed by pembrolizumab for up to a total of
35 cycles plus pemetrexed maintenance therapy | pemetrexed
and a platinum-based drug plus placebo every
3 weeks for 4 cycles, followed by placebo | participants with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease and without sensitizing EGFR or ALK mutations | | Keynote 407, 2018 | pembrolizumab + carboplatin and paclitaxel or nano particle albumin-bound paclitaxel (nab-paclitaxel) | carboplatin and paclitaxel or nano particle albumin-bound paclitaxel (nab-paclitaxel) | adults with first line metastatic squamous non-small cell lung cancer | | Keynote 042 (>=50%), 2018 | pembrolizumab
| SOC Treatment (Platinum-based Chemotherapy)
| Treatment Naïve Subjects With PD-L1 Positive Advanced or Metastatic Non-Small Cell Lung Cancer
| | Keynote 042 (>=20%), 2018 | pembrolizumab
| SOC Treatment (Platinum-based Chemotherapy)
| Treatment Naïve Subjects With PD-L1 Positive Advanced or Metastatic Non-Small Cell Lung Cancer
|
|
| Pembrolizumab | lung cancer (metastatic), in first line | vs platinum-based CT | by 28% [demonstrated] | by 48% [demonstrated] | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.72 [0.66 0.78] | p=0.04 | 0 | 3574 | 6 | Keynote 042 (>=1%), Keynote 024, KEYNOTE-021 phase 2, Keynote 189, Keynote 042 (>=50%), Keynote 042 (>=20%), | | progression or death (progression free survival PFS) | 0.52 [0.44 0.60] | p=0.04 | 0 | 1044 | 3 | Keynote 024, KEYNOTE-021 phase 2, Keynote 189, | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| Keynote 042 (>=1%), 2018 | pembrolizumab 200 mg every 3 wk for 35 cycles or until disease progression, intolerable toxicity | investigators choice of carboplatin plus paclitaxel or carboplatin plus pemetrexed for a maximum of 6 cycles | Treatment Naïve Subjects With PD-L1 Positive Advanced or Metastatic Non-Small Cell Lung Cancer | | Keynote 024, 2015 | Pembrolizumab (200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD
| standard of care (SOC) platinum-based chemotherapies
| previously
untreated advanced NSCLC with PD-L1 expression on at least 50% of tumor cells
and no sensitizing mutation of the epidermal growth factor receptor gene or translocation
of the anaplastic lymphoma kinase gene | | KEYNOTE-021 phase 2, 2016 | 24 months treatment with pembrolizumab (200mg every three weeks)+ CT | four cycles of carboplatin and pemetrexed (500 mg/m2 every three weeks) | patients with stage IIIB/IV, chemotherapy-naive, nonsquamous non-small-cell lung cancer | | Keynote 189, 2018 | pemetrexed
and a platinum-based drug plus 200 mg of pembrolizumab, followed by pembrolizumab for up to a total of
35 cycles plus pemetrexed maintenance therapy | pemetrexed
and a platinum-based drug plus placebo every
3 weeks for 4 cycles, followed by placebo | participants with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease and without sensitizing EGFR or ALK mutations | | Keynote 042 (>=50%), 2018 | pembrolizumab
| SOC Treatment (Platinum-based Chemotherapy)
| Treatment Naïve Subjects With PD-L1 Positive Advanced or Metastatic Non-Small Cell Lung Cancer
| | Keynote 042 (>=20%), 2018 | pembrolizumab
| SOC Treatment (Platinum-based Chemotherapy)
| Treatment Naïve Subjects With PD-L1 Positive Advanced or Metastatic Non-Small Cell Lung Cancer
|
|
| Pembrolizumab | lung cancer (metastatic), in second line | vs docetaxel | by 34% | by 17% | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.66 [0.57 0.76] | p=0.04 | 0 | 1377 | 2 | Keynote 010 2mg, Keynote 010 10mg, | | progression or death (progression free survival PFS) | 0.83 [0.74 0.94] | p=0.04 | 0 | 1377 | 2 | Keynote 010 2mg, Keynote 010 10mg, | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| Keynote 010 2mg, 2015 | pembrolizumab
2 mg/kg | docetaxel 75 mg/m² every 3 weeks | patients
with previously treated non-small-cell lung cancer with PD-L1 expression on at least 1% of tumour cells | | Keynote 010 10mg, 2015 | pembrolizumab
10 mg/kg
| docetaxel 75 mg/m² every 3 weeks
| patients
with previously treated non-small-cell lung cancer with PD-L1 expression on at least 1% of tumour cells |
|
| Pembrolizumab | lung cancer (metastatic), in first line | vs platinum-based CT | by 36% | - | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.64 [0.49 0.84] | p=0.04 | 0 | 204 | 1 | Keynote 407, | | progression or death (progression free survival PFS) | no data | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| Keynote 407, 2018 | pembrolizumab + carboplatin and paclitaxel or nano particle albumin-bound paclitaxel (nab-paclitaxel) | carboplatin and paclitaxel or nano particle albumin-bound paclitaxel (nab-paclitaxel) | adults with first line metastatic squamous non-small cell lung cancer |
|
| Pembrolizumab | melanoma, in all type of patients | vs pembrolizumab 10mg/kg | NS | NS | NS | NS | - | NS | NS | - | - | NS | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| 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, | | Adverse events leading to treatment discontinuation | 0.63 [0.21 1.85] | p=1.00 | 0 | 173 | 1 | KEYNOTE-001, | | objective response (ORR) | 0.99 [0.48 2.01] | p=1.00 | 0 | 157 | 1 | KEYNOTE-001, | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | 1.75 [0.66 4.63] | p=1.00 | 0 | 173 | 1 | KEYNOTE-001, | | Grade 3–5 drug-related AEs | 1.75 [0.66 4.63] | p=1.00 | 0 | 173 | 1 | KEYNOTE-001, | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | 6.61 [0.80 54.90] | p=1.00 | 0 | 173 | 1 | KEYNOTE-001, | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| KEYNOTE-001, 2014 | intravenous pembrolizumab at 2 mg/kg every 3 weeks | intravenous pembrolizumab at 10 mg/kg every 3 weeks | patients (aged ¡Ý18 years) with advanced melanoma whose disease had progressed after at least two ipilimumab doses |
|
| Pembrolizumab | melanoma, in all type of patients | vs chemotherapy | - | by 47% | - | - | - | - | - | - | - | - | - | - | by 355% | NS | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.53 [0.45 0.64] | p=0.04 | 0 | 719 | 2 | KEYNOTE 002 (2mg/kg Q3W), KEYNOTE 002 (10mg/kg Q3W), | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | 4.55 [1.53 13.51] | p=0.04 | 0 | 699 | 2 | KEYNOTE 002 (2mg/kg Q3W), KEYNOTE 002 (10mg/kg Q3W), | | vitiligo grade 3-4 | 0.96 [0.06 15.38] | p=1.00 | 0 | 699 | 2 | KEYNOTE 002 (2mg/kg Q3W), KEYNOTE 002 (10mg/kg Q3W), | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| KEYNOTE 002 (2mg/kg Q3W), 2015 | Pembrolizumab 2 mg/kg IV Q3W | investigator-choice
chemotherapy (paclitaxel plus carboplatin, paclitaxel, carboplatin, dacarbazine, or oral temozolomide) | patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAFV600 mutation positive, a BRAF inhibitor | | KEYNOTE 002 (10mg/kg Q3W), 2015 | intravenous pembrolizumab 10 mg/kg every 3 weeks | investigator-choice
chemotherapy (paclitaxel plus carboplatin, paclitaxel, carboplatin, dacarbazine, or oral temozolomide)
| patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAFV600 mutation positive, a BRAF inhibitor
|
|
| Pembrolizumab | melanoma, in all type of patients | vs ipilimumab | by 32% | by 42% | - | - | - | by 41% | by 41% | - | - | - | - | - | by 543% | NS | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.68 [0.57 0.81] | p=0.04 | 0 | 537 | 2 | KEYNOTE-006 (every 2W), KEYNOTE-006 (every 3W), | | progression or death (progression free survival PFS) | 0.58 [0.50 0.68] | p=0.04 | 0 | 537 | 2 | KEYNOTE-006 (every 2W), KEYNOTE-006 (every 3W), | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | 0.59 [0.42 0.82] | p=0.04 | 0 | 1067 | 2 | KEYNOTE-006 (every 2W), KEYNOTE-006 (every 3W), | | Grade 3–5 drug-related AEs | 0.59 [0.42 0.82] | p=0.04 | 0 | 1067 | 2 | KEYNOTE-006 (every 2W), KEYNOTE-006 (every 3W), | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | 6.43 [3.03 13.63] | p=0.04 | 0 | 1067 | 2 | KEYNOTE-006 (every 2W), KEYNOTE-006 (every 3W), | | vitiligo grade 3-4 | 0.92 [0.06 14.79] | p=1.00 | 0 | 1067 | 2 | KEYNOTE-006 (every 2W), KEYNOTE-006 (every 3W), | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| KEYNOTE-006 (every 2W), 2015 | pembrolizumab (at a dose of 10 mg per kilogram of body weight) every 2 weeks or every 3 weeks | four doses of ipilimumab (at 3 mg per kilogram) every 3 weeks | patients with advanced melanoma who had received no more than one previous systemic therapy for advanced disease | | KEYNOTE-006 (every 3W), 2015 | Pembrolizumab Every 3 Weeks
| Ipilimumab (Participants receive ipilimumab, 3 mg/kg IV, once every 3 weeks for a total oPembrolizumab Every 2 Weeks (Participants receive pembrolizumab, 10 mg intravenously (IV), once every 2 weeks for up to 2 years)
2/ Pembrolizumab Every 3 Weeks (P | patients with unresectable stage III or IV advanced melanoma and who had received no more than one previous
systemic therapy for advanced disease
|
|
| Pembrolizumab | melanoma, in all type of patients | vs placebo | - | by 43% | - | - | - | by 335% | by 335% | - | - | - | by 43% [demonstrated] | - | by 196% | NS | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| 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, | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | 4.35 [2.53 7.48] | p=0.04 | 0 | 1011 | 1 | KEYNOTE-054, | | Grade 3–5 drug-related AEs | 4.35 [2.53 7.48] | p=0.04 | 0 | 1011 | 1 | KEYNOTE-054, | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | 0.57 [0.43 0.75] | p=0.04 | 0 | 1019 | 1 | KEYNOTE-054, | | 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, | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| KEYNOTE-054, 2018 | Pembrolizumab (Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 1 year)
| placebo | patients with complete Resection of High-Risk Stage III Melanoma |
|
| Pembrolizumab | melanoma, in second line (or later) | vs pembrolizumab 10mg/kg | NS | NS | NS | NS | - | NS | NS | - | - | NS | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| 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, | | Adverse events leading to treatment discontinuation | 0.63 [0.21 1.85] | p=1.00 | 0 | 173 | 1 | KEYNOTE-001, | | objective response (ORR) | 0.99 [0.48 2.01] | p=1.00 | 0 | 157 | 1 | KEYNOTE-001, | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | 1.75 [0.66 4.63] | p=1.00 | 0 | 173 | 1 | KEYNOTE-001, | | Grade 3–5 drug-related AEs | 1.75 [0.66 4.63] | p=1.00 | 0 | 173 | 1 | KEYNOTE-001, | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | 6.61 [0.80 54.90] | p=1.00 | 0 | 173 | 1 | KEYNOTE-001, | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| KEYNOTE-001, 2014 | intravenous pembrolizumab at 2 mg/kg every 3 weeks | intravenous pembrolizumab at 10 mg/kg every 3 weeks | patients (aged ¡Ý18 years) with advanced melanoma whose disease had progressed after at least two ipilimumab doses |
|
| Pembrolizumab | melanoma, in second line (or later) | vs chemotherapy | - | by 47% | - | - | - | - | - | - | - | - | - | - | by 355% | NS | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.53 [0.45 0.64] | p=0.04 | 0 | 719 | 2 | KEYNOTE 002 (2mg/kg Q3W), KEYNOTE 002 (10mg/kg Q3W), | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | 4.55 [1.53 13.51] | p=0.04 | 0 | 699 | 2 | KEYNOTE 002 (2mg/kg Q3W), KEYNOTE 002 (10mg/kg Q3W), | | vitiligo grade 3-4 | 0.96 [0.06 15.38] | p=1.00 | 0 | 699 | 2 | KEYNOTE 002 (2mg/kg Q3W), KEYNOTE 002 (10mg/kg Q3W), | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| KEYNOTE 002 (2mg/kg Q3W), 2015 | Pembrolizumab 2 mg/kg IV Q3W | investigator-choice
chemotherapy (paclitaxel plus carboplatin, paclitaxel, carboplatin, dacarbazine, or oral temozolomide) | patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAFV600 mutation positive, a BRAF inhibitor | | KEYNOTE 002 (10mg/kg Q3W), 2015 | intravenous pembrolizumab 10 mg/kg every 3 weeks | investigator-choice
chemotherapy (paclitaxel plus carboplatin, paclitaxel, carboplatin, dacarbazine, or oral temozolomide)
| patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAFV600 mutation positive, a BRAF inhibitor
|
|
| Pembrolizumab | melanoma, in first line | vs ipilimumab | by 32% | by 42% | - | - | - | by 41% | by 41% | - | - | - | - | - | by 543% | NS | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.68 [0.57 0.81] | p=0.04 | 0 | 537 | 2 | KEYNOTE-006 (every 2W), KEYNOTE-006 (every 3W), | | progression or death (progression free survival PFS) | 0.58 [0.50 0.68] | p=0.04 | 0 | 537 | 2 | KEYNOTE-006 (every 2W), KEYNOTE-006 (every 3W), | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | 0.59 [0.42 0.82] | p=0.04 | 0 | 1067 | 2 | KEYNOTE-006 (every 2W), KEYNOTE-006 (every 3W), | | Grade 3–5 drug-related AEs | 0.59 [0.42 0.82] | p=0.04 | 0 | 1067 | 2 | KEYNOTE-006 (every 2W), KEYNOTE-006 (every 3W), | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | 6.43 [3.03 13.63] | p=0.04 | 0 | 1067 | 2 | KEYNOTE-006 (every 2W), KEYNOTE-006 (every 3W), | | vitiligo grade 3-4 | 0.92 [0.06 14.79] | p=1.00 | 0 | 1067 | 2 | KEYNOTE-006 (every 2W), KEYNOTE-006 (every 3W), | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| KEYNOTE-006 (every 2W), 2015 | pembrolizumab (at a dose of 10 mg per kilogram of body weight) every 2 weeks or every 3 weeks | four doses of ipilimumab (at 3 mg per kilogram) every 3 weeks | patients with advanced melanoma who had received no more than one previous systemic therapy for advanced disease | | KEYNOTE-006 (every 3W), 2015 | Pembrolizumab Every 3 Weeks
| Ipilimumab (Participants receive ipilimumab, 3 mg/kg IV, once every 3 weeks for a total oPembrolizumab Every 2 Weeks (Participants receive pembrolizumab, 10 mg intravenously (IV), once every 2 weeks for up to 2 years)
2/ Pembrolizumab Every 3 Weeks (P | patients with unresectable stage III or IV advanced melanoma and who had received no more than one previous
systemic therapy for advanced disease
|
|
| Pembrolizumab | melanoma, in adjuvant setting | vs placebo | - | by 43% | - | - | - | by 335% | by 335% | - | - | - | by 43% [demonstrated] | - | by 196% | NS | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| 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, | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | 4.35 [2.53 7.48] | p=0.04 | 0 | 1011 | 1 | KEYNOTE-054, | | Grade 3–5 drug-related AEs | 4.35 [2.53 7.48] | p=0.04 | 0 | 1011 | 1 | KEYNOTE-054, | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | 0.57 [0.43 0.75] | p=0.04 | 0 | 1019 | 1 | KEYNOTE-054, | | 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, | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| KEYNOTE-054, 2018 | Pembrolizumab (Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 1 year)
| placebo | patients with complete Resection of High-Risk Stage III Melanoma |
|
| Pembrolizumab | multiple myeloma, in all type of patients | vs lenalidomide, dexamethasone | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| KEYNOTE-185, 2018 | | lenalidomide and low-dose dexamethasone | newly diagnosed and treatment naïve Multiple Myeloma who are ineligible for autologous stem cell transplant |
|
| Pembrolizumab | multiple myeloma, in all type of patients | vs pomadoline + dexamethasone | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| KEYNOTE-183, 2018 | pembrolizumab, Pomalidomide and low-dose Dexamethasone | Pomalidomide and low-dose Dexamethasone | refractory or relapsed and refractory Multiple Myeloma (rrMM) |
|
| Pembrolizumab | urothelial carcinoma (advanced), in all type of patients | vs | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | no data | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| KEYNOTE-052, 2017 | intravenous pembrolizumab 200 mg every 3 weeks | | cisplatin-ineligible patients with advanced urothelial cancer who had not been previously treated with systemic chemotherapy |
|
| Pembrolizumab | urothelial carcinoma (advanced), in all type of patients | vs chemotherapy | by 27% | NS | - | - | - | - | - | - | - | - | - | - | - | - | - | | Endpoint | TE [95% CI] | p val | I2 | n | k | trials |
|---|
| death (overall survival) | 0.73 [0.59 0.91] | p=0.04 | 0 | 542 | 1 | KEYNOTE-045, | | progression or death (progression free survival PFS) | 0.98 [0.81 1.19] | p=1.00 | 0 | 542 | 1 | KEYNOTE-045, | | Adverse events leading to treatment discontinuation | no data | | objective response (ORR) | no data | | treatment-emergent adverse events (TEAEs) | no data | | Grade 3–5 drug-related AEs | no data | | Grade 3–5 drug-related AEs | no data | | treatment-related deaths | no data | | complete response (CR) | no data | | serious drug-related adverse events | no data | | recurrence free survival | no data | | toxic death | no data | | vitiligo any grade | no data | | vitiligo grade 3-4 | no data | | distant metastasis free survival | no data |
TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients | Trial | Studied treatment | Control | Patients |
|---|
| KEYNOTE-045, 2017 | pembrolizumab | investigators choice of chemotherapy with paclitaxel, docetaxel, or vinflunine | patients with advanced urothelial cancer that recurred or progressed after platinum-based chemotherapy | | Keynote 361 monotherapy, | pembrolizumab 200 mg every 3 weeks (Q3W) | chemotherapy alone | patients with histologically or cytologically confirmed unresectable/metastatic urothelial carcinoma |
|
