Table 2.
Test parameters for PD-L1 22C3 IHC pharmDxTM in CBs compared to LTRs
| TPS cutoff | Total cohort (n = 81) |
Before interim analysis (n = 43) |
After interim analysis (n = 38) |
|||
|---|---|---|---|---|---|---|
| ≥50% | ≥1% | ≥50% | ≥1% | ≥50% | ≥1% | |
| Sensitivity | 66.7 (41.0, 86.7) | 73.5 (55.6, 87.1) | 77.8 (40.0, 97.2) | 73.7 (48.8, 90.0) | 55.6 (21.2, 86.3) | 73.7 (44.9, 92.2) |
| Specificity | 95.2 (86.7, 99.0) | 72.3 (57.4, 84.4) | 91.2 (76.3, 98.1) | 70.8 (48.9, 87.4) | 100.0 (88.1, 100) | 73.9 (51.6, 89.8) |
| Accuracy | 88.9 (80.0, 94.8) | 72.8 (61.8, 82.1) | 88.4 (74.9, 96.1) | 72.1 (56.3, 84.7) | 89.5 (75.2, 97.1) | 73.7 (56.9, 86.6) |
| PPV | 80.0 (51.9, 95.7) | 65.8 (48.6, 80.4) | 70.0 (34.8, 93.3) | 66.7 (43.0, 85.4) | 100.0 (47.8, 100) | 64.7 (38.3, 85.8) |
| NPV | 90.9 (81.3, 96.6) | 79.1 (64.0, 90.0) | 93.9 (79.8, 99.3) | 77.3 (54.6, 92.2) | 87.9 (71.8, 96.6) | 81.0 (58.1, 94.6) |
| FPR | 4.8 (1.0, 13.3) | 27.7 (15.6, 42.6) | 8.8 (1.9, 23.7) | 29.2 (12.6, 51.1) | 0.0 (0, 11.9) | 26.1 (10.2, 48.4) |
| FNR | 33.3 (13.3, 59.0) | 26.5 (12.9, 44.4) | 22.2 (2.8, 60.0) | 26.3 (9.1, 51.2) | 44.4 (13.7, 78.8) | 26.7 (7.8, 55.1) |
All values are in percentage (%) and 95% confidence intervals are within parentheses. PD-L1, programmed death ligand-1; IHC, immunohistochemistry; CB, cell block; LTR, lung tumor resection; FNR, false-negative rate; FPR, false-positive rate; NPV, negative predictive value; PPV, positive predictive value; TPS, tumor proportion score.