Table 1. Biomarkers and immunotherapy.
Study and drug used | Biomarker | Outcome measure | P* |
---|---|---|---|
Keynote-024, Reck et al. (1st line pembrolizumab) | PD-L1 ≥50% | HR for death: 0.60 | 0.005 |
Keynote-010, Herbst et al. (2nd line pembrolizumab) | PD-L1 ≥1% | HR for death: 0.71 | 0.0008 |
Checkmate-017, Brahmer et al. (2nd line nivolumab) | PD-L1 ≥1% | HR for death: 0.59 | <0.001 |
PD-L1 <1% | HR for death: 0.59 | ||
Checkmate-057, Borghaei et al. (2nd line nivolumab) | PD-L1 ≥1% | HR for death: 0.73 | 0.002 |
PD-L1 <1% | Not significant | ||
OAK, Rittmeyer et al. (2nd line atezolizumab) | TC1/2/3 or IC1/2/3 | HR for death: 0.74 | 0.0003 |
TC0 or IC0 | HR for death: 0.75 | ||
Checkmate-227, Hellmann et al. (1stline: nivolumab + ipilimumab) | TMB ≥10 MPM + PD-L1 ≥1% | HR for PD or death: 0.62 | <0.001 |
TMB ≥10 MPM + PD-L1 <1% | HR for PD or death: 0.48 | ||
Uryvaev et al. (ICI therapy) | CD8+ count: under 886/mm2 | RR to ICI: 16.7% | 0.046 |
CD8+ count:886 to 1,899/mm2 | RR to ICI: 60% | 0.017 | |
CD8+/CD4+ ratios <2 | RR to ICI: 13.3% | 0.035 | |
CD8+/CD4+ ratios >2 | RR to ICI: 43% to 50% | ||
Sanmamed et al. (ICI therapy) | Serum IL-8 early change >9.2% | AUC: 1.00; sensitivity: 85.7%; specificity: 100%; | 0.0004 |
Kato et al. (ICI therapy) | MDM2 family amplification | OR for TTF >11.9 | 0.001 |
*, statistically significant results for P<0.05. ICI, immune checkpoint inhibitors; PD-L1, programmed death ligand 1; TC, tumor cells; IC, immune cells; TMB, tumor mutational burden; MPM, mutations per megabase; CD8+, CD8-expressing tumor infiltrating lymphocytes; CD4+, CD4-expressing tumor infiltrating lymphocytes; IL-8, interleukine-8; MDM2, mouse double minute 2 homolog; HR, hazard ratio; PD, progression of disease; RR, response rate; AUC, area under the curve; OR, odds ratio; TTF, time to treatment failure.