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.
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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