Table 4.
Effect of avelumab on 89 refined immune cell subsets
| 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