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| Histology | Biomarker | Trial/author | Drugs | Setting | Study results |
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| Urothelial | PD-L1 (CPS) | KEYNOTE 052 (phase 2) | Pembrolizumab | 1-line CDDP ineligible | 24% ORR, highest ORR in patients with CPS ≥ 10% |
| | PD-L1 (CPS) | KEYNOTE 045 (phase 3) | Pembrolizumab vs CHT | Second line after platinum-based CHT | Higher ORR in pembrolizumab group than CHT, regardless of tumor PD-L1 expression |
| | PD-L1 (IHC) | NCT02108652 (phase 2) | Atezolizumab | ≥2-line after platinum-based CHT (cohort 2) | ORR: 26% (PD-L1 ≥ 5%) vs 15% (all patients)
OS: 11.4 (PD-L1 ≥ 5%) vs 7.9 (all patients) months |
| | PD-L1 (IHC) | NCT02108652 (phase 2) | Atezolizumab | First-line CDDP ineligible | No significant enrichment of response and OS by PD-L1 expression |
| | PD-L1 (IHC) | NCT01772004 (phase 1b) | Avelumab | ≥2-line treatment after platinum-based CHT | Patients with higher PD-L1 ≥ 5% showed higher response rates and longer PFS and OS |
| | PD-L1 (IHC) | CheckMate 275 (phase 2) | Nivolumab | ≥2-line treatment after platinum-based CHT | ORR: 28.4% (PD-L1 ≥ 5%) vs 23.8% (PD-L1 ≥ 1%) vs 16.1 (PD-L1 < 1%); OS: 11.3 (PD-L1 ≥ 1%) vs 5.9 (PD-L1 < 1%) months |
| | CXCL9, CXCL10 cytokines | CheckMate 275 (phase 2) | Nivolumab | ≥2-line treatment after platinum-based CHT | Positive predictors of response to nivolumab |
| | CXCL9, CXCL10 cytokines PD-L1 rabbit SP142 (Ventana) | IMvigor 210 (phase 2) | Atezolizumab | ≥2-line after platinum-based CHT (cohort 2) | Positive predictors of response to atezolizumab; PD-L1 expression on IC (>5% of cells) was significantly associated with response. In contrast, PD-L1 expression in tumor cells was not associated with response |
| | PD-L1 (IHC) | NCT01693562 (phase 2) | Durvalumab | ≥2-line treatment after platinum-based CHT | No differences in PFS and ORR between high and low/negative PD-L1 patients |
| | dMMR or MSI-H | G. Iyer et al., J Clin Oncol 2017 | ICIs | Metastatic setting | dMMR caused a high mutation load and was associated to durable responses to ICIs |
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| Kidney | PD-L1 rabbit 28-8 (Dako) | CheckMate 214 (phase 3) | Nivolumab ipilimumab vs sunitinib | First line | Greater benefit in ORR, PFS, and OS for patients with PD-L1 ≥ 1% treated with nivolumab and ipilimumab |
| | PD-L1 (IHC) | Javelin renal 101 | Avelumab plus axitinib vs sunitinib | First line | Greater benefit in ORR and PFS in patients with treated with avelumab plus axitinib, independently from PD-L1 |
| | PD-L1 (IHC) | KEYNOTE 423 (phase 3) | Pembrolizumab plus axitinib vs sunitinib | First line | Greater benefit in ORR, OS, and PFS in patients with treated with pembrolizumab plus axitinib, independently of PD-L1 |
| | PD-L1 (IHC) rabbit SP142 (Ventana) | IMmotion 151 (phase 3) | Bevacizumab/atezolizumab vs sunitinib | 1-line | PFS in PD-L1 ≥ 1% patients: 11.2 mo (with atezolizumab plus bevacizumab) vs 7.7 mo (with sutent), HR 0.74, P = 0.0217 |
| | PD-L1 (IHC) rabbit 28-8 (Dako) | CheckMate 025 (phase 3) | Nivolumab vs everolimus | ≥2-line treatment after anti-VEGFR therapy | No differences in OS on the basis of PD-L1 status |
| | SII rabbit 28-8 (Dako) | De Giorgi et al., Clin Cancer Research 2019 | Retrospective analysis of EAP of nivolumab | ≥2-line treatment after anti-VEGFR therapy | Normal body mass index combined with higher SII tripled the risk of death |
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| Prostate | dMMR | Le DT et al., Science 2017 | Pembrolizumab | Advanced dMMR cancers | ORR: 53% of patients and complete responses were achieved in 21% of patients |
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