|
Post
|
Subset
|
Increase
|
Minimal change
|
Decrease
|
Unadjusted P-value
|
Direction
|
Holm adjusted P-value
|
|---|
|
1 cycle
|
PD-1+ ICOS+ CD4
|
12 (63%)
|
5 (26%)
|
2 (11%)
|
0.0181
|
↑
|
0.5611
|
| |
PD-1+ Tregs
|
12 (63%)
|
5 (26%)
|
2 (11%)
|
0.0141
|
↑
|
0.0705
|
| |
Functional intermediate NK
|
10 (53%)
|
6 (31%)
|
3 (16%)
|
0.0401
|
↑
|
0.5213
|
|
3 cycles
|
Functional intermediate NK
|
1 (7%)
|
4 (29%)
|
9 (64%)
|
0.0295
|
↓
|
0.4130
|
|
9 cycles
|
CTLA-4+ EM CD8
|
9 (56%)
|
6 (38%)
|
1 (6%)
|
0.0250
|
↑
|
0.6250
|
| |
Functional intermediate NK
|
2 (12%)
|
4 (25%)
|
10 (63%)
|
0.0386
|
↓
|
0.5018
|
| |
PD-1+ pDC
|
10 (63%)
|
2 (12%)
|
4 (25%)
|
0.0335
|
↑
|
0.1005
|
| |
CD16+ MDSC
|
9 (56%)
|
5 (31%)
|
2 (13%)
|
0.0092
|
↑
|
0.1288
|
| |
gMDSC
|
11 (69%)
|
2 (12%)
|
3 (19%)
|
0.0131
|
↑
|
0.1703
|
| |
CD16+ gMDSC
|
10 (62%)
|
3 (19%)
|
3 (19%)
|
0.0155
|
↑
|
0.1705
|
| |
PD-1+ lin neg MDSC
|
10 (62%)
|
4 (25%)
|
2 (13%)
|
0.0182
|
↑
|
0.1820
|
- The frequency of 89 refined immune cell subsets was examined pre-therapy and post-1 cycle (n=19), 3 cycles (n=14), and 9 cycles (n=16) of avelumab. Table displays subsets that met criteria as a potentially biologically relevant trend. Results are displayed as the number of patients (percentage of total patients) with an increase of more than 25%, minimal change of less than 25%, and a decrease of more than 25% compared to pre-therapy. Unadjusted p-values (direction of change compared to pre-therapy) were calculated using the Wilcoxon matched-pairs signed rank test, and Holm adjustment was made for the number of subsets within the classic subsets with a frequency above 0.01% of PBMC
-
EM effector memory, gMDSC granulocytic MDSC, ICOS inducible T cell co-stimulator, lin neg MDSC lineage negative MDSC, MDSC myeloid derived suppressor cell, NK natural killer, pDC plasmacytoid DC, PD-1 programmed cell death protein 1, Tregs regulatory T cells
