Industry News: Agilent companion diagnostic expands CE-IVD mark in Europe to include esophageal cancer

PD-L1 IHC 22C3 pharmDx can now be used as an aid to identify esophageal cancer patients for treatment with KEYTRUDA (pembrolizumab)

24 Aug 2021


Agilent Technologies has announced that the company’s PD-L1 IHC 22C3 pharmDx assay has expanded its use in Europe. The assay is now CE-IVD marked for use as an aid in identifying esophageal cancer patients for treatment with KEYTRUDA® using combined positive score (CPS) ≥ 10.1 In Europe, KEYTRUDA is approved in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with locally advanced unresectable or metastatic esophageal carcinoma or HER2 negative gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (CPS ≥ 10).2

“PD-L1 has been established as an essential biomarker for anti-PD-1 therapies like KEYTRUDA,” said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. “Pathologists’ confidence in their PD-L1 test is critical, as a growing number of patients are becoming eligible for treatment with these therapies. With expanded use of our PD-L1 IHC 22C3 pharmDx assay, Agilent can provide pathologists with the quality, reliability, and accuracy they need to ensure diagnostic confidence.

In Europe, almost 53,000 people were diagnosed with esophageal cancer in 2020, and this type of cancer caused more than 45,000 deaths the same year.3

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.2 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 MSD.

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References

1. PD-L1 IHC 22C3 pharmDx [package insert]. Carpinteria, CA: Dako, Agilent Pathology Solutions; 2021. 
2. Keytruda [Summary of Product Characteristics]. European Medicines Agency; 2021. 
3. World Health Organization. Global Cancer Observatory. https://gco.iarc.fr/today/data/factsheets/populations/908-europe-fact-sheets.pdf (accessed August 10, 2021).