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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.
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Journal of Translational Medicine

ISSN: 1479-5876

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