Table 3.
Response rate assessment
| Cohort | CR/PR | SD/PD | p- value# |
||
|---|---|---|---|---|---|
| Cohort B | p16 IHC N=42 (%) | Positive (N=18) | 5 (28) | 13 (72) | 0.27 |
| Negative (N=24) | 11 (46) | 13 (54) | |||
| PD-L1 IHC N=39 (%) | CPS < 1 (N=7) | 1 (14) | 6 (86) | 0.32 | |
| CPS 1-19 (N=13) | 5 (39) | 8 (62) | |||
| CPS >= 1 (N=19) | 9 (47) | 10 (53) | |||
| Cohort A + B | p16 IHC N=85 (%) | Positive (N=39) | 7 (18) | 32 (82) | 0.02 |
| Negative (N=46) | 19 (41) | 27 (59) | |||
| PD-L1 IHC N=76 (%) | CPS < 1 (N=14) | 1 (7) | 13 (93) | 0.03 | |
| CPS 1-19 (N=26) | 7 (27) | 19 (73) | |||
| CPS >=20 (N=36) | 16 (44) | 20 (56) | |||
| Prior cetuximab or immunotherapy exposure* N=85 (%) | Yes (N=29) | 6 (21) | 23 (79) | 0.16 | |
| No (N=56) | 20 (36) | 36 (64) | |||
| Platinum resistant disease+ N=85 (%) | Yes (N=12) | 5 (42) | 7 (58) | 0.46 | |
| No (N=73) | 21 (29) | 52 (71) | |||
| TTMV DNA in plasma N=35 (%) | > median (high, N=17) | 0 (0) | 17 (100) | 0.01 | |
| < median (low, N=18) | 6 (33) | 12 (67) |
CR: completed response, PR: partial response, SD: stable disease, PD: progressive disease, IHC: immunohistochemical staining, PD-L1: Programmed cell death ligand 1, CPS: combined positive score, TTMV: tumor-tissue-modified human papillomavirus.
*
Exclude cetuximab given with radiation
+
Relapse within 6 months of platinum containing curative therapy
#
p value is derived from the Barnard unconditional test for 2 × 2 tables, and CMH test otherwise.