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Table 4 Association of clinical activity with tumor biomarkers.

From: A prospective phase II trial exploring the association between tumor microenvironment biomarkers and clinical activity of ipilimumab in advanced melanoma

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

  1. *P-values are for tests of association between biomarker and clinical activity and are uncorrected for multiple testing.
  2. H&E: hematoxylin and eosin; IDO: indoleamine 2,3-dioxygenase; IHC: immunohistochemistry; TILs: tumor-infiltrating lymphocytes.