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PD-L1 biomarker testing
for KEYTRUDA®

Precision medicine in oncology is guided by biomarker testing

If you’re looking to learn more about PD-L1 (Programmed Death Ligand 1) biomarker testing or determine if KEYTRUDA® (pembrolizumab) is a treatment option for a patient, this site has information that could be useful to you.

Use this site to:

Learn about scoring and reporting PD-L1 status
Determine appropriate patients for treatment with KEYTRUDA®

The PD-L1 biomarker

PD-1 is an immune-checkpoint receptor that limits the activity of T lymphocytes in peripheral tissues. The PD-1 pathway is an immune control checkpoint that may be engaged by tumour cells to inhibit active T-cell immune surveillance. KEYTRUDA® is a high affinity antibody against PD-1, which exerts dual ligand blockade of the PD-1 pathway, including PD-L1 and PD-L2, on antigen presenting or tumour cells. By inhibiting the PD-1 receptor from binding to its ligands, KEYTRUDA® reactivates tumour-specific cytotoxic T lymphocytes in the tumour microenvironment.¹

PD-L1 biomarker testing in certain tumour types by CPS (combined positive score) or TPS (tumour proportion score) can help to determine appropriate patients for treatment with KEYTRUDA®.¹

Which KEYTRUDA® indications require PD-L1 testing?

Test PD-L1 expression in the following indications¹

KEYTRUDA® is indicated for:

NSCLC (non-small cell lung carcinoma)

For the 1L monotherapy treatment of adult patients with metastatic NSCLC or stage III disease where patients are not candidates for surgical resection or definitive chemoradiation, expressing PD-L1 (TPS ≥ 1%) as determined by a validated test, with no EGFR or ALK genomic tumour aberrations; a positive association was observed between the level of PD-L1 expression and the magnitude of the treatment benefit
For monotherapy treatment of adult patients with metastatic NSCLC whose tumours express PD-L1 (TPS ≥ 1%) as determined by a validated test and who have disease progression on or after platinum-containing chemotherapy; patients with EGFR or ALK genomic tumour aberrations should have received an authorized therapy for these aberrations prior to receiving KEYTRUDA®

HNSCC (head and neck squamous cell carcinoma)

For the 1L monotherapy treatment of metastatic or unresectable recurrent HNSCC in adult patients whose tumours have PD-L1 expression (CPS ≥ 1) as determined by a validated test

TNBC (triple-negative breast cancer)

In combination with chemotherapy, for the treatment of adult patients with locally recurrent unresectable or metastatic TNBC, who have not received prior chemotherapy for metastatic disease and whose tumours express PD-L1 (CPS ≥ 10) as determined by a validated test. Consult the description of the study for the chemotherapy (paclitaxel, nab-paclitaxel or gemcitabine/carboplatin) and dosing regimens used.

Cervical cancer

In combination with chemotherapy with or without bevacizumab, for the treatment of adult patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1 (CPS ≥ 1) as determined by a validated test

Gastric Cancer or Gastroesophageal Junction (GEJ) Adenocarcinoma

In combination with trastuzumab, fluoropyrimidine- and platinum- containing chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours express PD-L1 (CPS ≥ 1) as determined by a validated test

Learn about scoring and reporting PD-L1 status