Biomarker Navigator

PD-L1

Also known as CD274

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Tumour types

gastric cancer, non-small cell lung cancer, triple-negative breast cancer, urothelial carcinoma

CD274 encodes programmed death-ligand 1 (PD-L1), an immune checkpoint protein whose expression on tumor and/or immune cells is used as a predictive biomarker for checkpoint inhibitor response.

The clinically reported measure is protein expression level (Tumor Proportion Score or Combined Positive Score by IHC), not a DNA sequence variant.

Clinical significance

  • PD-L1 expression level, scored by a validated IHC assay, is used to inform eligibility and sequencing for immune checkpoint inhibitor therapy across several tumor types; the specific scoring system and threshold are assay- and indication-specific.

    fda — FDA-approved product labeling and companion diagnostic labeling

  • PD-L1 IHC assays differ across approved companion diagnostics; scores are not interchangeable between assay platforms without harmonization data.

    pmc — PMC Open Access Subset, oncology literature

FDA-approved treatments

  • Tecentriq (atezolizumab) — PD-L1-selected NSCLC and triple-negative breast cancer indications (assay- and indication-specific thresholds) [fda]
  • Imfinzi (durvalumab) — Unresectable stage III NSCLC after chemoradiotherapy, and other PD-L1-relevant indications [fda]
  • Opdivo (nivolumab) — PD-L1-expressing and PD-L1-unselected indications across NSCLC, urothelial carcinoma, gastric/GEJ adenocarcinoma, and other tumor types (assay- and indication-specific) [fda]
  • Keytruda (pembrolizumab) — PD-L1-expressing NSCLC, urothelial carcinoma, triple-negative breast cancer, gastric/GEJ adenocarcinoma, and other PD-L1-selected indications (assay- and indication-specific thresholds) [ema]

Prevalence

PD-L1 expression thresholds and prevalence vary substantially by tumor type and assay; high PD-L1 expression (TPS >= 50%) is seen in approximately 25%-30% of NSCLC by validated companion diagnostic assays. [fda]

Tests / detection method

IHC

Therapeutic pipeline

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