Table 1. Characteristics of the 78 patients analyzed in this trial stratified by those who did or did not develop CBR or toxicity to pembrolizumab.
Of the entire INSPIRE cohort (n=106), 28 patients did not have paired baseline and pre-cycle 3 serum for analysis and thus were excluded.
| No. (%) of patients | No. (%) of patients | ||||||
|---|---|---|---|---|---|---|---|
| Covariates | With CBR (n=24) | Without CBR (n=54) | p-value | With toxicity (n=19) | Without toxicity (n=59) | p-value | |
| Sex, female | 12 (50) | 31 (57) | 0.62 a | 7 (37) | 36 (61) | 0.11 a | |
| Ethnicity, white | 20 (83) | 44 (83) | >0.99 a | 18 (95) | 46 (79) | 0.17 a | |
| Age at time of first pembrolizumab infusion, median (range), years | 62 (34–82) | 58 (21–78) | 0.38 b | 58 (28–73) | 61 (21–82) | 0.95 b | |
| Cohort | A: HNSCC | 3 (13) | 11 (20) | 0.011 a | 3 (16) | 11 (19) | 0.15 a |
| B: TNBC | 1 (4) | 11 (20) | 1 (5) | 11 (19) | |||
| C: HGSOC | 2 (8) | 10 (19) | 3 (16) | 9 (15) | |||
| D: Melanoma | 8 (33) | 3 (6) | 6 (32) | 5 (9) | |||
| E: Mixed solid tumor | 10 (42) | 19 (35) | 6 (32) | 23 (39) | |||
| PD-L1 MPS positive cells ≥ 1% | 16 (67) | 24 (44) | 0.088 a | 11 (58) | 29 (49) | 0.6 a | |
| % PD-L1 MPS positive cells, median (range) | 1.5 (0-100) | 0 (0-95) | 0.029 b | 2 (0-100) | 0 (0-95) | 0.12 b | |
CBR = clinical benefit rate; HGSOC = high-grade serous ovarian carcinoma; HNSCC = head and neck squamous cell carcinoma; MPS = modified percent score; TNBC = triple negative breast cancer.
a P-value calculated by Fisher Exact Test, unadjusted.
b P-value calculated by Mann-Whitney, unadjusted.