Table 1.
Clinical trials assessing PD-L1 expression as a predictive biomarker for clinical response to ICBs.
| Therapies | Tumor type | Target cells | Detection Ab | Cut-off | PD-L1+ | PD-L1− | P value | Reference |
|---|---|---|---|---|---|---|---|---|
| Nivolumab | Melanoma, NSCLC, CRC, RCC, prostate cancer | Tumor | 5H1 | 5% | 36% (9/25) | 0% (0/17) | P = 0.006 | 15 |
| Ipilimumab + Nivolumab (concurrent) | Melanoma | Tumor | 28–8 | 5% | 46% (6/13) | 41% (9/22) | P > 0.99 | 39 |
| Ipilimumab + Nivolumab (sequenced) | 50% (4/8) | 8% (1/13) | Unknown | |||||
| Atezolizumab | NSCLC | TILs | SP142 | 1% | 31% (8/26) | 20% (4/20) | P = 0.015 | 34 |
| 5% | 40% (6/13) | 18% (6/33) | ||||||
| 10% | 83% (5/6) | 18% (7/40) | ||||||
| All tumors studied (melanoma, NSCLC and others) | TILs | 1% | 29% (26/90) | 13% (8/60) | P = 0.007 | |||
| 5% | 34% (19/56) | 16% (15/94) | ||||||
| 10% | 46% (15/33) | 16% (19/117) | ||||||
| NSCLC | Tumor | 1% | 25% (3/12) | 26% (9/34) | P = 0.920 | |||
| 5% | 33% (3/9) | 24% (9/37) | ||||||
| 10% | 38% (3/8) | 24% (9/38) | ||||||
| All tumors studied (melanoma, NSCLC and others) | Tumor | 1% | 31% (9/29) | 18% (22/121) | P = 0.079 | |||
| 5% | 39% (7/18) | 18% (24/132) | ||||||
| 10% | 47% (7/15) | 18% (24/135) | ||||||
| Nivolumab | Nonsquamous NSCLC | Tumor | 28–8 | 1% | 31% (28/123) | 9% (10/108) | P = 0.002 | 21 |
| 5% | 36% (34/95) | 10% (14/136) | P = 0.002 | |||||
| 10% | 37% (32/86) | 11% (16/145) | P = 0.002 | |||||
| Nivolumab | Squamous NSCLC | Tumor | 28–8 | 1% | 17% (11/63) | 17% (9/54) | P = 0.9364 | 22 |
| 5% | 21% (9/42) | 15% (11/75) | P = 0.2908 | |||||
| 10% | 19% (7/36) | 16% (13/81) | P = 0.6411 | |||||
| Pembrolizumab | NSCLC | Tumor | 22C3 | 50% | 45% (33/73) | 15% (20/131) | p < 0.01 | 18 |
| 1% | 28% (50/176) | 11% (3/28) | ||||||
| Ipilimumab + Nivolumab | Melanoma | Tumor | 28–8 | 5% | 72% (49/68) | 55% (115/210) | Unknown | 12 |
| Nivolumab | Melanoma | 58% (46/80) | 41% (86/208) | |||||
| Ipilimumab | Melanoma | 21% (16/75) | 18% (36/202) | |||||
| Ipilimumab + Nivolumab | Melanoma | Tumor | SP142 | 5% | 58% (14/24) | 55% (31/56) | Unknown | 25 |
| Ipilimumab | Melanoma | 18% (2/11) | 4% (1/27) | |||||
| Nivolumab | Untreated metastatic melanoma | Tumor | 28–8 | 5% | 53% (39/74) | 33% (45/136) | Unknown | 19 |
| Pembrolizumab | NSCLC | Tumor | 50% | 45% (69/154) | Unknown | Unknown | 24 | |
| Atezolizumab | Urothelial carcinoma | TILs | SP142 | 1% | 22% (45/207) | 13% (13/103) | Unknown | 35 |
| 5% | 27% (27/100) | 15% (31/210) | ||||||
| Nivolumab | NSCLC | Tumor | 28–8 | 5% | 26 (55/211) | Unknown | Unknown | 26 |
| Atezolizumab + Paclitaxel | TNBC | TIICs | 1% | 59 (109/185) | 54 (143/265) | 38 |
Note: Ipilimumab: anti-CTLA-4; Nivolumab, Pembrolizumab: anti-PD-1; Atezolizumab: anti-PD-L1; NSCLC: non-small cell lung cancer; CRC: colorectal cancer; RCC: renal cell carcinoma; TNBC: triple-negative breast cancer; TILs: tumor-infiltration T cells; TIICs: tumor-infiltrating immune cells; percentages (%) indicate rates of objective response.