Table 1.
Patient demographics by PHBR score (< 0.5 vs. ≥ 0.5) (N = 83)
| Variable | Group | N (82) | PHBR < 0.5 (N = 32) | PHBR ≥ 0.5 (N = 51) | Relative risk (95% CI)1 | P value2 |
|---|---|---|---|---|---|---|
| Sex | Male | 46 | 22 (48%) | 24 (52%) | 1.77 (0.96–3.26) | 0.07 |
| Female | 37 | 10 (27%) | 27 (73%) | |||
| Ethnicity | Caucasian | 71 | 27 (38%) | 44 (62%) | 0.91 (0.44–1.90) | > 0.99 |
| Others3 | 12 | 5 (42%) | 7 (58%) | |||
| Age4 (years) | < 60 | 17 | 6 (35%) | 11 (65%) | 0.90 (0.44–1.82) | > 0.99 |
| ≥ 60 | 66 | 26 (39%) | 40 (61%) | |||
| Tumor type | Head and neck SCC | 9 | 4 (44%) | 5 (56%) | 1.18 (0.54–2.58) | 0.73 |
| Others | 74 | 28 (38%) | 46 (62%) | |||
| NSCLC | 26 | 7 (27%) | 19 (73%) | 0.61 (0.31–1.23) | 0.16 | |
| Others | 57 | 25 (44%) | 32 (56%) | |||
| Cutaneous SCC | 10 | 7 (70%) | 3 (30%) | 2.04 (1.22–3.42) | 0.04 | |
| Others | 73 | 26 (34%) | 48 (66%) | |||
| Others5 | 38 | 14 (37%) | 24 (63%) | 0.92 (0.53–1.60) | 0.82 | |
| Head and neck SCC, NSCLC, and cutaneous SCC | 45 | 18 (40%) | 27 (60%) | |||
| TMB6 (mutations/mb) | < 50 | 65 | 21 (32%) | 44 (68%) | 0.49 (0.28–0.83) | 0.048 |
| ≥ 50 | 12 | 8 (67%) | 4 (33%) | |||
| < 20 | 56 | 18 (32%) | 38 (68%) | 0.61 (0.35–1.07) | 0.12 | |
| ≥ 20 | 21 | 11 (52%) | 10 (48%) | |||
| < 10 | 38 | 11 (29%) | 27 (71%) | 0.63 (0.34–1.15) | 0.16 | |
| ≥ 10 | 39 | 18 (46%) | 21 (54%) | |||
| PD-1/L1 Therapy | Monotherapy | 66 | 26 (39%) | 40 (61%) | 1.12 (0.55–2.27) | > 0.99 |
| Combination | 17 | 6 (35%) | 11 (65%) | |||
| Overall benefit rate | SD ≥ 6 months/PR/CR7 | 36 | 17 (47%) | 19 (53%) | 1.45 (0.84–2.49) | 0.25 |
| Others | 46 | 15 (33%) | 31 (67%) | |||
| PD | 32 | 7 (22%) | 25 (78%) | 0.45 (0.22–0.91) | 0.02 | |
| Others | 51 | 25 (49%) | 26 (51%) |
1Relative risk for PHBR < 0.5
2Calculated using Fisher’s exact test
3Others: African American (N = 2), Asian (N = 4), Hispanic (N = 5), and unknown (N = 1)
4At time of initiation of treatment with immunotherapy
5Others: adrenal (N = 1), appendix (N = 4), basal cell carcinoma (N = 3), breast cancer (N = 6), cervical (N = 1), cholangiocarcinoma (N = 1), colorectal (N = 2), duodenal (N = 1), gastroesophageal (N = 5), glioblastoma (N = 2), thyroid (N = 1), prostate (N = 1), rectal squamous cell carcinoma (N = 1), renal cell carcinoma (N = 1), sarcoma (N = 3), urothelial (N = 4), and urethral squamous cell carcinoma (N = 1)
6TMB was performed on 77 patients
7One patient had SD, but had not reached to 6 months. Only 82 patients were evaluable for this comparison
Abbreviations: CR complete response, HR hazard ratio, NR not reached to 50%, NSCLC non-small cell lung cancer, OS overall survival, PFS progression-free survival, PD progressive disease, PHBR Patient Harmonic-mean Best Rank, PR partial response, RR relative risk, SCC squamous cell carcinoma, SD stable disease, TMB tumor mutational burden