Agilent PD-L1 IHC 22C3 pharmDx Expands CE-IVD mark in Non-small Cell Lung Cancer (NSCLC)

Rhea-AI Summary

Agilent Technologies (NYSE: A) has expanded the labeling of its PD-L1 IHC 22C3 pharmDx assay for use in patients with non-small cell lung cancer (NSCLC) in the European Union. The assay helps identify NSCLC patients with Tumor Proportion Score (TPS) ≥ 50% for treatment with Libtayo® (cemiplimab). Lung cancer is the leading cause of cancer death, with NSCLC accounting for about 85% of cases. This initiative underscores Agilent's commitment to developing diagnostics for targeted cancer therapy.

Positive

• Expanded use of PD-L1 IHC 22C3 pharmDx assay in Europe increases market potential.
• Collaboration with Sanofi and Regeneron enhances credibility and reach in cancer diagnostics.

Negative

• None.

Agilent Technologies Inc. (NYSE: A) today announced that the company’s PD-L1 IHC 22C3 pharmDx assay is now labeled for expanded use in patients with non-small cell lung cancer (NSCLC) in the European Union. 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). 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 overall and the 2^nd most commonly diagnosed cancer in Europe.¹ NSCLC makes up approximately 85% of all lung cancer cases.² In Europe, the average five-year survival rate for lung cancer is less than 20%.³

“This expanded indication for PD-L1 IHC 22C3 pharmDx will enable pathologists in Europe to identify patients with NSCLC who may be eligible for treatment with Libtayo,” said Sam Raha, president of Agilent's Diagnostics and Genomics Group. “This further demonstrates Agilent’s commitment to partnering with leading pharmaceutical companies to develop IHC-based diagnostics for targeted cancer therapy.”

Anti-PD-1 immunotherapies such as Libtayo offer new treatment options for patients with advanced NSCLC.⁴ Sanofi and Regeneron 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 (Study 1624) clinical trial.⁴

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.⁴

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. World Health Organization. Global Cancer Observatory. https://gco.iarc.fr/today/data/factsheets/populations/908-europe-fact-sheets.pdf (accessed February 26, 2021).
2. Wood, R.; Taylor-Stokes, G.; Smith, F.; Chaib, C. The Humanistic Burden of Advanced Non-Small Cell Lung Cancer (NSCLC) in Europe: A Real-World Survey Linking Patient Clinical Factors to Patient and Caregiver Burden. Qual. Life Res. 2019, 28 (7), 1849–1861
3. Lung Cancer Europe. 4th LuCE report on lung cancer: Early diagnosis and screening challenges in lung cancer. https://www.lungcancereurope.eu/wp-content/uploads/2019/11/WEB-VERSION-IV-LuCE-Report.pdf.pdf (accessed June 24, 2021).
4. Libtayo [Summary of Product Characteristics]. European Medicines Agency; 2021.

    

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FAQ

What is the significance of the expanded use of PD-L1 IHC 22C3 pharmDx assay by Agilent Technologies?

The expanded use allows pathologists in Europe to identify NSCLC patients suitable for Libtayo treatment.

When did Agilent Technologies announce the expanded indication for its PD-L1 IHC 22C3 pharmDx assay?

Agilent Technologies announced the expanded indication on July 20, 2021.

How does the PD-L1 IHC 22C3 pharmDx assay assist in cancer treatment?

It aids in identifying NSCLC patients with tumor PD-L1 expression of Tumor Proportion Score (TPS) ≥ 50% for Libtayo treatment.

What is Libtayo and its relevance in the context of NSCLC?

Libtayo is a monoclonal antibody that targets PD-1, offering new treatment options for patients with advanced NSCLC.