Agilent PD-L1 IHC 22C3 pharmDx Extends CE-IVD Mark in Non-Small Cell Lung Cancer (NSCLC)

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SANTA CLARA, Calif .– (COMMERCIAL THREAD) –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 the identification of patients with NSCLC with PD-L1 tumor expression with a tumor proportion score (TPS) ≥ 50% for treatment with Libtayo® ( cemiplimab). This announcement underscores Agilent’s continued commitment to the development of IHC-based diagnostics for the treatment of cancer.

Lung cancer is the leading cause of cancer death overall and the 2sd most commonly diagnosed cancer in Europe.1 NSCLC accounts for about 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 allow European pathologists 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 once again demonstrates Agilent’s commitment to partnering with leading pharmaceutical companies to develop IHC-based diagnostics for the targeted treatment of cancer.

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 assess PD-L1 expression in patients in the EMPOWER-Lung 1 pivot (Study 1624) clinical test.4

Libtayo is a fully human monoclonal antibody targeting the PD-1 immune checkpoint receptor on T cells. By binding to PD-1, Libtayo has been shown to prevent 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 the life sciences, diagnostics and applied chemicals markets, providing information and innovations to improve quality of life. Agilent instruments, software, services, solutions and people provide reliable answers to customers’ most complex questions. The company generated sales 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 Agilent Writing. Follow Agilent on LinkedIn, Twitter, and Facebook.

The references:

  1. World Health Organization. World 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 investigation linking clinical factors of patients to patient and caregiver burden. Qual. Res. 2019, 28 (7), 1849-1861
  3. Lung cancer Europe. 4th LuCE report on lung cancer: challenges of early diagnosis and screening for 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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