Agilent Companion Diagnostic Expands CE-IVD Mark in Europe to Include Triple-Negative Breast Cancer


Agilent Technologies Inc. announced that its PD-L1 IHC 22C3 pharmDx assay is now labelled for use in TNBC in the European Union. PD-L1 expression is a critical biomarker for response to anti-PD-1 therapies such as KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy manufactured by Merck (known as MSD outside the United States and Canada). The expanded use of PD-L1 IHC 22C3 pharmDx strengthens the ability of pathologists to identify patients who may be eligible for treatment with KEYTRUDA. In Europe, KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic TNBC in adults whose tumors express PD-L1 [Combined Positive Score (CPS) ≥ 10] and who have not received prior chemotherapy for metastatic disease.1

PD-L1 IHC 22C3 pharmDx is the only clinical trial proven PD-L1 assay CE-IVD–marked as an aid in identifying TNBC patients for treatment with KEYTRUDA. PD-L1 IHC 22C3 pharmDx now helps physicians in Europe identify patients for treatment with KEYTRUDA in five cancer types: non-small cell lung cancer (NSCLC), urothelial carcinoma, head and neck squamous cell carcinoma (HNSCC), esophageal cancer and triple-negative breast cancer (TNBC).2

“Anti-PD-1 therapies like KEYTRUDA continue to offer new treatment options for cancer patients,” said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. “This indication expansion of PD-L1 IHC 22C3 pharmDx in TNBC will allow physicians in Europe access to critical information to qualify even more patients who could benefit from these treatments. This further demonstrates Agilent’s role as a leader in developing companion diagnostics for targeted therapies.”

Breast cancer is the most common type of cancer among women, with more than 530,000 new cases diagnosed in Europe in 2020.3 Approximately 15-20% of breast cancer diagnoses are TNBC.4

KEYTRUDA is a humanized monoclonal antibody that enhances the ability of the immune system to detect and fight tumor cells. KEYTRUDA blocks the PD-1 pathway, thereby activating T-lymphocytes that may affect both tumor cells and healthy cells.1 KEYTRUDA and other targeted immunotherapies are changing cancer treatment, and their therapeutic value is being realized across a growing list of cancer types. PD-L1 IHC 22C3 pharmDx was developed by Agilent as a companion diagnostic for KEYTRUDA in partnership with Merck.

About Agilent Technologies

Agilent is a leader in life sciences, diagnostics, and applied chemical markets, delivering innovative technology solutions that provide trusted answers to researchers’ most challenging scientific questions. The company generated revenue of $5.34 billion in fiscal year 2020 and employs 16,400 people worldwide.