Table 3.
Predictive biomarkers of response to immune checkpoint inhibitors in clinical trials.
| Biomarker | ORR (%) | PFS (Months) | OS (Months) |
|---|---|---|---|
| Second line and beyond | |||
| PDL1 TPS [12] | Not predictive value: similar benefit regardless PDL1 | ||
| PDL1 CPS [13,14] | ORR 33 in CPS > 1 35.7 vs. 6 in CPS ≥ 1 vs. <1 |
2.1 vs. 1.9 in CPS ≥ 1 vs. <1 | 14.6 vs. 7.7 in CPS ≥ 1 vs. <1 |
| TMB [12] | 21.3 vs. 6.8 vs. 4.8 in patients receiving nivolumab with high, medium, and low TMB tertile, respectively. | 1.3 vs. 1.3 vs. 1.4 in patients receiving nivolumab with high, medium, and low TMB tertile, respectively. | 3.1 vs. 3.9 vs. 5.4 in patients receiving nivolumab with high, medium, and low TMB tertile, respectively. |
| 46.2 vs. 16 vs. 22.2 in patients receiving nivolumab + ipilimumab with high, medium, and low TMB tertile. | 1.5 vs. 1.3 vs. 7.8 in patients receiving nivolumab + ipilimumab with high, medium, and low TMB tertile, respectively. | 3.4 vs. 3.6 vs. 22 in patients receiving nivolumab + ipilimumab with high, medium, and low TMB tertile, respectively. | |
| First line | |||
| Tumor or immune PDL1 expression [15,17] | Not predictive value among patients with PDL1 ≥ 1% or ≥5%. Patients with PD-L1 < 1% derived the highest level of benefit from addition of atezolizumab to chemotherapy (HR 0.51). |
||
| Similar benefit regardless PDL1 from addition to durvalumab. | |||
| PDL1 CPS [19] | Not predictive value: similar benefit from addition to pembrolizumab regardless PDL1. | Not predictive value: similar benefit from addition to pembrolizumab regardless PDL1. | |
| TMB [17] | Not predictive value: similar benefit from addition of durvalumab irrespective of TMB. | ||
| Blood-based TMB [15] | Not predictive value: similar benefit from addition of atezolizumab: ≥10 mut/Mb HR 0.70; >10 mut/Mb HR 0.68; <16 mut/Mb HR 0.71; ≥16 mut/Mb HR 0.63 | ||
ORR: objective response rate, PFS: progression-free survival, OS: overall survival, TPS: tumor proportion score, CPS: combined positive score, TMB: tumor mutational burden: HR: hazard ratio, mut/Mb: mutations per megabase, PD-L1: programmed cell death ligand 1.