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).
TIL = tumor infiltrating lymphocytes. H&E = hematoxylin and eosin. NA = not available.
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).
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.