Agilent PD-L1 IHC 22C3 pharmDx Receives Expanded FDA Approval in Non-small Cell Lung Cancer (NSCLC)

Rhea-AI Summary

Agilent Technologies Inc. (NYSE: A) announced FDA approval for its PD-L1 IHC 22C3 pharmDx assay, expanding its application to non-small cell lung cancer (NSCLC) patients with tumor PD-L1 expression of Tumor Proportion Score (TPS) ≥ 50%. This diagnostic aids in identifying eligibility for treatment with Libtayo® (cemiplimab-rwlc), an anti-PD-1 therapy. Agilent's assay is the only FDA-approved companion diagnostic for this purpose, enhancing pathologist confidence in patient assessments and reinforcing Agilent's leadership in companion diagnostics for cancer therapies.

Positive

• FDA approval of PD-L1 IHC 22C3 pharmDx for NSCLC enhances market positioning.
• Unique FDA-approved diagnostic for Libtayo® treatment increases competitive edge.
• Potential to significantly improve patient outcomes in advanced NSCLC.

Negative

• None.

Agilent Technologies Inc. (NYSE: A) today 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.^1,2 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.³

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.²

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.³

About Agilent Technologies

Agilent Technologies Inc. (NYSE: A) is a global leader in life sciences, diagnostics, and applied chemical markets, delivering insight and innovation toward improving the quality of life. Agilent instruments, software, services, solutions, and people provide trusted answers to customers' most challenging questions. The company generated revenue of $5.34 billion in fiscal 2020 and employs 16,400 people worldwide. Information about Agilent is available at www.agilent.com. To receive the latest Agilent news, subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn, Twitter, and Facebook.

References: 1. Lung and Bronchus Cancer – Cancer Stat Facts. https://seer.cancer.gov/statfacts/html/lungb.html (accessed Nov 24, 2020). 2. “Non–Small Cell Lung Cancer: Epidemiology, Screening, Diagnosis, and Treatment.” https://www.mayoclinicproceedings.org/article/S0025-6196(19)30070-9/fulltext (accessed Nov 24 2020). 3. Libtayo [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals Inc.; 2021.

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FAQ

What is the purpose of the PD-L1 IHC 22C3 pharmDx assay approved by Agilent?

The PD-L1 IHC 22C3 pharmDx assay is used to identify non-small cell lung cancer patients eligible for treatment with Libtayo based on tumor PD-L1 expression.

When was the PD-L1 IHC 22C3 pharmDx assay approved by the FDA?

The PD-L1 IHC 22C3 pharmDx assay was approved by the FDA as of the announcement on February 22, 2021.

What is Libtayo and how does it relate to Agilent's assay?

Libtayo is an anti-PD-1 therapy developed to treat advanced NSCLC, and Agilent's assay is the FDA-approved companion diagnostic that helps identify eligible patients.

What market potential does the FDA approval of Agilent's assay signify?

The FDA approval positions Agilent to capture a significant share in the diagnostics market for lung cancer, particularly for NSCLC patients eligible for immunotherapy.

What role does Agilent play in the development of cancer diagnostics?

Agilent is a pioneer in developing companion diagnostics, enhancing pathologists' ability to report findings that influence treatment decisions for cancer patients.