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Agilent Technologies Obtains CE Mark for Expanded Use of PD-L1 CDx in NSCLC

NEW YORK ─ Agilent Technologies on Tuesday announced that it has received CE marking for the expanded use of its PD-L1 IHC 22C3 pharmDx companion diagnostic assay in patients with non-small cell lung cancer.

Santa Clara, California-based Agilent said the assay can be used by pathologists in Europe to help identify NSCLC patients for treatment with cemiplimab (Regeneron Pharmaceuticals and Sanofi's Libtayo) based on a PD-L1 expression tumor proportion score, or TPS, of at least 50 percent.

Cemiplimab is a monoclonal antibody that targets the immune checkpoint receptor PD-1 on T-cells. Sanofi and Regeneron developed the monoclonal antibody and partnered with Agilent for the use of PD-L1 IHC 22C3 pharmDx to evaluate PD-L1 expression in patients in the pivotal EMPOWER-Lung 1 clinical trial. By binding to PD-1, cemiplimab has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation, Agilent said.

In February, the US Food and Drug Administration approved Agilent's PD-L1 IHC 22C3 pharmDx as a companion diagnostic for identifying NSCLC patients eligible for cemiplimab treatment based on a PD-L1 expression TPS of at least 50 percent.

In 2016, Agilent's Dako subsidiary obtained CE marking for the PD-L1 IHC 22C3 pharmDx as a companion diagnostic to identify best responders to the anti-PD-1 immunotherapy pembrolizumab (Merck's Keytruda).