Table 4.
Association of clinical activity with tumor biomarkers.
| Biomarker | Observed Effect | P-value* | |
|---|---|---|---|
| Benefit Group (n = 21) |
Non-benefit Group (n = 43) |
||
| TILs change from baseline to week 4, by H&E | 4/7 increase 0/7 decrease 3/7 no change |
2/20 increase 3/20 decrease 15/20 no change |
0.005 |
| FoxP3 expression at baseline, by IHC | 6/8 evaluable patients positive | 9/25 evaluable patients positive | 0.014 |
| IDO expression at baseline, by IHC | 3/8 evaluable patients positive | 3/27 evaluable patients positive | 0.012 |
*P-values are for tests of association between biomarker and clinical activity and are uncorrected for multiple testing.
H&E: hematoxylin and eosin; IDO: indoleamine 2,3-dioxygenase; IHC: immunohistochemistry; TILs: tumor-infiltrating lymphocytes.