Industry News: Agilent PD-L1 IHC 22C3 pharmDx receives expanded FDA approval in non-small cell lung cancer

Companion diagnostic can help guide treatment decisions in cases of NSCLC

23 Feb 2021


Agilent Technologies Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved the company’s PD-L1 IHC 22C3 pharmDx assay for expanded use in patients with non-small cell lung cancer (NSCLC). PD-L1 IHC 22C3 pharmDx can now be used as an aid in identifying NSCLC patients with tumor PD-L1 expression of Tumor Proportion Score (TPS) ≥ 50% for treatment with Libtayo® (cemiplimab-rwlc). This announcement underscores Agilent's continuing commitment to the development of IHC-based diagnostics for cancer therapy.

Lung cancer is the leading cause of cancer death in both men and women in the United States, with NSCLC making up 85% of all lung cancer cases. PD-L1 expression is a biomarker for response to anti-PD-1 therapy in NSCLC; this expanded indication enables pathologists to identify patients with advanced NSCLC who may be eligible for treatment with Libtayo. Currently, PD-L1 IHC 22C3 pharmDx is the only companion diagnostic with FDA approval for this use.

"Anti-PD-1 therapies, including Libtayo, continue to broaden the potential for the treatment of patients across different cancer types,” said Sam Raha, president of Agilent's Diagnostics and Genomics Group. "With the FDA approval of PD-L1 IHC 22C3 pharmDx as a companion diagnostic for treatment with Libtayo monotherapy in advanced NSCLC, Agilent further strengthens its ability to elevate pathologist confidence in reporting results to oncologists and bolsters our role as a global pioneer in developing companion diagnostics for targeted treatments."

Regeneron and Sanofi developed Libtayo 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.

PD-1 immunotherapies such as Libtayo offer new treatment options for patients with advanced NSCLC, for whom the 60-month overall survival rate is  0–10% in patients with stage IVA–IVB disease.

Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.

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