Agilent PD-L1 IHC 28-8 pharmDx Receives CE-IVD Mark as a Companion Diagnostic Test in Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

Rhea-AI Summary

Agilent Technologies Inc. (NYSE: A) has received CE-IVD mark approval for the PD-L1 IHC 28-8 pharmDx, intended to assist in first-line treatment decisions for adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal cancers. Gastric and esophageal cancers are significant global health issues, with over 1.6 million cases reported in 2020. The PD-L1 IHC 28-8 pharmDx enhances treatment confidence when used with OPDIVO® (nivolumab), demonstrating superior survival rates compared to chemotherapy alone.

Positive

• Received CE-IVD mark approval for PD-L1 IHC 28-8 pharmDx.
• Improves treatment options for patients with advanced gastric and esophageal cancers.
• Demonstrated superior overall survival and progression-free survival rates when used with OPDIVO®.

Negative

• None.

SANTA CLARA, Calif.--(BUSINESS WIRE)-- Agilent Technologies Inc. (NYSE: A) today announced it has received CE-IVD mark approval for the PD-L1 IHC 28-8 pharmDx to guide options for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal cancers.

Gastric (stomach) cancer is the fifth most common cancer and the fourth leading cause of cancer death worldwide, with over 1,000,000 new cases and approximately 770,000 deaths in 2020.¹ Esophageal cancer is the seventh most common cancer and the sixth leading cause of death from cancer worldwide, with approximately 600,000 new cases and over 540,000 deaths in 2020. ¹ Together with cancers of the gastroesophageal junction, they constitute an important – and growing – global health concern.

PD-L1 is a critical biomarker for response to anti-PD-1 therapies, including the immunotherapeutic agent OPDIVO® (nivolumab). When used in conjunction with the PD-L1 IHC 28-8 pharmDx as a companion test, treatment with Opdivo® in combination with chemotherapy provides the first and only PD-1-directed treatment to demonstrate superior overall survival (OS) and progression-free survival (PFS) when compared to chemotherapy alone in patients with advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma whose tumors express PD-L1 with a combined positive score (CPS) ≥ 5.

"The added indication of PD-L1 IHC 28-8 pharmDx will give physicians in Europe important information to inform first-line treatment decisions for patients with these common and potentially deadly cancers," said Sam Raha, president of the Agilent’s Diagnostics and Genomics Group. "Agilent values opportunities such as this to partner with pharmaceutical companies in the development of clinically relevant IHC-based or NGS-based diagnostics that enhance confidence in targeted cancer therapy."

This approval builds on Agilent's previous successes in expanding the applicability of PD-L1 IHC tests and marks the latest milestone in their ongoing commitment to drug/diagnostic co-development.

About Agilent Technologies

Agilent is a leader in life sciences, diagnostics, and applied chemical markets, delivering innovative technology solutions that provide trusted answers to researchers’ most challenging scientific questions. The company generated revenue of $5.34 billion in fiscal year 2020 and employs 16,400 people worldwide. Information about Agilent is available at www.agilent.com. To receive the latest Agilent news, please subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn, Twitter, and Facebook.

References:

1. Sung, H., Ferlay, J., Siegel, R. L., Laversanne, M., Soerjomataram, I., Jemal, A., & Bray, F. (2021). Global cancer statistics 2020: Globocan estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians, 71(3), 209–249. https://doi.org/10.3322/caac.21660

View source version on businesswire.com: https://www.businesswire.com/news/home/20211021005619/en/

Naomi Goumillout

Agilent Technologies

+1.781.266.2819

naomi.goumillout@agilent.com

Source: Agilent Technologies Inc.

FAQ

What is the recent approval received by Agilent Technologies (NYSE: A)?

Agilent Technologies has received CE-IVD mark approval for the PD-L1 IHC 28-8 pharmDx.

How does the PD-L1 IHC 28-8 pharmDx aid cancer treatment?

It assists in first-line treatment decisions for patients with HER2-negative advanced gastric, gastroesophageal junction, or esophageal cancers.

What cancers does the PD-L1 IHC 28-8 pharmDx target?

It targets advanced gastric and esophageal cancers, which are major global health concerns.

What is the significance of PD-L1 IHC 28-8 pharmDx in cancer therapy?

It enhances treatment confidence and has shown superior survival rates with OPDIVO® compared to chemotherapy alone.