Skip to main content

Advertisement

Table 4 Analysis of immunological parameters in tumor biopsies.

From: Phase I/II open-label study of the biologic effects of the interleukin-2 immunocytokine EMD 273063 (hu14.18-IL2) in patients with metastatic malignant melanoma

Evaluation Pre-Dose Biopsy Post-Dose Biopsy    
  Negative Positive1 NA Decreased2 No Change Increased2 Increased, then Decreased NA
GD2 2 5 2 3 3 0 1 2
S100 0 7 2 0 4 3 0 2
HLA-A 1 5 3 1 2 1 0 5
TIL by H&E 5 0 4 0 4 0 1 4
TIL by granzyme B 6 1 2 0 4 3 0 2
TIL by CD3 5 2 2 1 1 4 1 2
TIL by CD3zeta 5 2 2 1 3 3 0 2
TIL by CD8 5 2 2 1 3 3 0 2
TIL by CD16 1 6 2 0 6 1 0 2
TIL by CD56 6 0 3 0 4 0 0 5
  1. Number of patients with negative and positive evaluations in pre-treatment (screen or day 1 of cycle 1) tumor biopsy specimens and changes in biology markers in tumor biopsies after exposure to EMD 273063 (1 or 2 cycles).
  2. TIL = tumor infiltrating lymphocytes. H&E = hematoxylin and eosin. NA = not available.
  3. 1. ≥ 50% of cells with 1+ or greater staining intensity (GD2, S100, or HLA-A), or ≥ 1.0 cell/HPF (cells per high power field).
  4. 2. Increase or decrease determined by change in >10% cells (or an excess in changes of >10% of cells), or a change in number of cells/HPF from below to above or above to below 1.0, or from below to above or above to below 10.