Objective:

To identify patients whose tumors express programmed death ligand 1 (PD-L1) for potential treatment eligibility with nivolumab or nivolumab and hyaluronidase-nvhy.

Approach:

• Diagnostic Approval: The FDA approved Agilent Technologies' PD-L1 IHC 28-8 pharmDx assay for use with the Agilent Autostainer Link 48.

Key Findings:

• The assay is designed for patients with esophageal squamous cell carcinoma, gastric tumors, gastroesophageal junction tumors, and esophageal adenocarcinoma.
• A Combined Positive Score of 1 or greater indicates PD-L1 expression suitable for treatment consideration, measuring PD-L1 staining in tumor and immune cells relative to the total number of viable tumor cells.
• Esophageal cancer has over 510,000 new cases and 445,000 deaths annually; gastric cancer has approximately 968,000 new cases and 660,000 deaths.

Interpretation:

The PD-L1 IHC 28-8 pharmDx assay serves as a diagnostic aid in identifying patients for potential treatment with nivolumab or nivolumab and hyaluronidase-nvhy.

Conclusion:

The assay assists pathologists and clinicians in making treatment decisions for patients with specific cancer types.

Sources:

• Agilent Technologies Press Release