Agilent Companion Diagnostic Expands CE-IVD Mark for PD-L1 IHC 28-8 pharmDx to Include Esophageal Squamous Cell Carcinoma
SANTA CLARA, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) today announced it has expanded CE-IVD marking in the European Union for its PD-L1 IHC 28-8 pharmDx as an aid in identifying esophageal squamous cell carcinoma patients for treatment with Bristol Myers Squibb’s PD-1-targeted immunotherapeutic OPDIVO® (nivolumab), in combination with fluoropyrimidine and platinum-based chemotherapy or OPDIVO® in combination with YERVOY® (ipilimumab). These combined treatments provide new hope for patients diagnosed with these cancers.
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. The two most common types of esophageal cancer are squamous cell carcinoma and adenocarcinoma, which account for approximately 85% and 15% of all esophageal cancers, respectively, though esophageal tumor histology can vary by region and country.
PD-L1 is a critical biomarker for response to anti-PD-1 therapies, including the immunotherapeutic agent OPDIVO® based on the Phase 3 CheckMate-648 trial results. When used in conjunction with PD-L1 IHC 28-8 pharmDx as a companion test, first-line treatment with OPDIVO® in combination with chemotherapy or in combination with YERVOY® provides PD-1-directed treatment to demonstrate superior overall survival when compared to chemotherapy alone in patients with unresectable advanced, recurrent, or metastatic previously untreated esophageal squamous cell carcinoma with tumor cell PD-L1 expression ≥ 1%.
“With the CE marking of expanded use in Europe of our PD-L1 IHC 28-8 pharmDx assay, Agilent enables pathologists the increased capability to identify patients with ESCC for first-line treatment with OPDIVO® in combination with chemotherapy or YERVOY® (ipilimumab)," said Sam Raha, president of Agilent's Diagnostics and Genomics Group. “We greatly value our relationship with Bristol Myers Squibb, and are committed to continuing developing and commercializing market-leading companion diagnostic products.”
Agilent is the worldwide leader in partnering with pharmaceutical companies to develop IHC-based diagnostics for targeted cancer therapy. With the expansion of PD-L1 IHC 28-8 pharmDx, Agilent continues to set the standard and lead with innovation, quality, and ease of implementation—furthering their ongoing commitment to fight cancer and enable new discoveries.
1. Bray, F.; Ferlay, J.; Soerjomataram, I.; Siegel, R.; Torre, L.; Jemal, A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA A Cancer J. Clin. 2018, 68, 394–424. https://doi.org/10.3322/caac.21492
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