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Table 1 The FDA-approved anti-PD1 drug and PD-L1 assessment

From: PD-L1 expression and the prognostic significance in gastric cancer: a retrospective comparison of three PD-L1 antibody clones (SP142, 28–8 and E1L3N)

mAb

Drug

FDA approval

Scoring assessment

Overall response rate

22C3 pharmDx (Dako North America, Inc.)

Pembrolizumab (KEYTRUDA®)

NSCLC

TPSa < 1%: No PD-L1 expression

TPS = 1~ 49%: PD-L1 expression

TPS ≥ 50%: High PD-L1 expression

NCT02007070

TPS ≥ 1%:15.4% (95% CI: 4.4–34.9%)

TPS ≥ 50%:27.3% (95% CI: 6.0–61.0%)

Gastric or GEJ adenocarcinoma

CPSb < 1: No PD-L1 expression

CPS≥: PD-L1 expression

NCT02335411

CPS ≥ 1: 13.3% (95% CI: 8.2–20.0%)

28–8 pharmDx (Dako North America, Inc.)

Nivolumab (OPDIVO ®)

Melanoma

TC < 1%c: No PD-L1 expression

TC ≥ 1%d: PD-L1 expression

NCT01721746

PD-L1 ≥ 5%: 5.49% (95% CI: 1.92–19.08%)

PD-L1 < 5%: 1.13% (95% CI: 0.44–3.16%)

Non-squamous NSCLC

TC < 1%e: No PD-L1 expression

TC ≥ 1%f: PD-L1 expression

NCT01673867

PD-L1 ≥ 1%: 30.9% (95% CI: 22.9–39.9%)

PD-L1 < 1%: 9.3% (95% CI: 4.5–16.4%)

SP142 Assay (VENTANA MEDICAL SYSTEMS, INC)

Atezolizumab (TECENTRIQ)

NSCLC

TC ≥ 50%g: PD-L1 expression

IC ≥ 10%: PD-L1 expression

TC < 50% and IC < 10%6: PD-L1 expression

NCT01846416

PD-L1 expression: 16.1% (95% CI:9.32 to 25.2%)

SP263 Assay (VENTANA MEDICAL SYSTEMS, INC)

Durvalumab (IMFINZI™)

Urothelial Carcinoma

TC ≥ 25%: High PD-L1 expression

ICP7 > 1% and IC + 7 ≥ 25%: High PD-L1 expression

ICP = 1% and IC+ = 100%: High PD-L1 expression

None of the criteria for PD-L1 High Status are met: Low/negative PD-L1 expression

NCT01693562

High PD-L1: 27.6% (95% CI: 19–37.5%)

Low/negative PD-L1: 5.1% (1.4–12.5%)

  1. CI confidence interval, CPS combined positive score, FDA Food and Drug Administration, GEJ gastroesophageal junction tumor, ICP immune cells present, NSCLC non-small cell lung cancer, PD-1, programmed death receptor 1, PD-L1 programmed death ligand 1, TPS tumor proportion score, TC tumor cell
  2. a The percentage of viable tumor cells showing partial or complete membrane staining at any intensity
  3. b The number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100
  4. c Specimen is considered PD-L1 negative if < 1% of melanoma cells exhibit circumferential and/or partial linear plasma membrane PD-L1 staining of tumor cells at any intensity. The entire specimen must be evaluated
  5. d Specimen is considered PD-L1 positive if ≥1% of melanoma cells exhibit circumferential and/or partial linear plasma membrane PD-L1 staining of tumor cells at any intensity. The entire specimen must be evaluated
  6. e Non-malignant cells and immune cells (e.g., infiltrating lymphocytes or macrophages) may also stain with PD-L1; however, these should not be included in the scoring for the determination of PD-L1 positivity
  7. f TC are scored as the percentage of tumor cells with the presence of discernible PD-L1 membrane staining of any intensity. IC are scored as the proportion of tumor area, including associated intratumoral and contiguous peritumoral stroma, occupied by PD-L1 staining IC of any intensity
  8. g The percent of tumor area occupied by any tumor-associated immune cells (Immune Cells Present, ICP) is used to determine IC+, which is the percent area of ICP exhibiting PD-L1 positive immune cell staining is also evaluated at any intensity
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Diagnostic Pathology

ISSN: 1746-1596

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