Clinical Report: FDA Expands Test for Gastric and Esophageal Cancers

Overview

The FDA has approved Agilent Technologies' PD-L1 IHC 28-8 pharmDx assay for identifying patients with specific gastric and esophageal cancers who may be eligible for nivolumab treatment. This approval applies to patients with esophageal squamous cell carcinoma, gastric tumors, gastroesophageal junction tumors, and esophageal adenocarcinoma.

Background

Esophageal and gastric cancers are significant global health concerns, with high incidence and mortality rates. The introduction of companion diagnostics like the PD-L1 IHC 28-8 pharmDx assay aims to assist in identifying patients eligible for immunotherapy based on PD-L1 expression.

Data Highlights

The PD-L1 IHC 28-8 pharmDx assay is approved for use with the Agilent Autostainer Link 48 and is intended for patients with tumors expressing PD-L1 (Combined Positive Score of 1 or greater), which measures PD-L1 staining in tumor and immune cells relative to viable tumor cells.

Key Findings

• The PD-L1 IHC 28-8 pharmDx assay is now FDA-approved for use in gastric and esophageal cancers.
• Eligible patients include those with esophageal squamous cell carcinoma and gastric tumors.
• Clinical studies, including CheckMate-648 and CheckMate-649, have reported findings related to overall survival and progression-free survival with nivolumab treatment.
• Esophageal cancer ranks as the 11th most common cancer globally, while gastric cancer is the fifth most common.

Clinical Implications

The approval of the PD-L1 IHC 28-8 pharmDx assay provides clinicians with a tool to identify patients who may be eligible for nivolumab therapy.

Conclusion

The FDA's approval of the PD-L1 IHC 28-8 pharmDx assay represents a step in identifying patients for targeted immunotherapy in gastric and esophageal cancers.

Related Resources & Content

1. Agilent Technologies, Press Release, 2024 -- FDA Expands Test for Gastric and Esophageal Cancers
2. The ASCO Post — New Assays, Surveillance Techniques Reported for GI Malignancies
3. The ASCO Post — Use of Cell-Free DNA Methylation–Based Blood Test in Detecting Gastrointestinal Cancers
4. Gastric Cancer — Gender-based prognostic implications of CD66b-positive tumor-infiltrating neutrophils in gastric and esophageal adenocarcinomas
5. The ASCO Post — Noninvasive, Multitarget Stool DNA Methylation Assay Under Study in Early Detection of Multiple Gastrointestinal Cancers
6. FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection | FDA
7. Immunotherapy and Targeted Therapy for Advanced Gastroesophageal Cancer: ASCO Living Guideline
8. These highlights do not include all the information needed to use OPDIVO safely and effectively. See full prescribing information for OPDIVO.OPDIVO® (nivolumab) injection, for intravenous useInitial U.S. Approval: 2014
9. Premarket Approval (PMA)
10. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial - PubMed
11. Nivolumab plus chemotherapy as first-line treatment for advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma: 5-year follow-up results from CheckMate 649 - PubMed
12. The efficacy and safety of PD-1/PD-L1 inhibitors plus chemotherapy versus chemotherapy alone in advanced or metastatic gastric or gastroesophageal junction cancer: a meta-analysis of randomized controlled trials - PubMed
13. Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma | New England Journal of Medicine
14. Nivolumab plus chemotherapy or ipilimumab versus chemotherapy in patients with advanced esophageal squamous cell carcinoma (CheckMate 648): 29‐month follow‐up from a randomized, open‐label, phase III trial - Kato - 2024 - Cancer Medicine - Wiley Online Library
15. ESMO Clinical Practice Guideline interim update on the treatment of locally advanced oesophageal and oesophagogastric junction adenocarcinoma and metastatic squamous-cell carcinoma - PMC