Clinical Report: FDA expands gastroesophageal cancer options

Overview

The FDA has approved two first-line treatment regimens containing zanidatamab-hrii for adults with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma. These regimens are based on results from the ongoing phase 3 HERIZON-GEA-01 trial.

Background

Gastroesophageal adenocarcinoma is a significant health concern, with approximately 20% of patients exhibiting HER2-positive disease. The recent FDA approvals expand treatment options for this patient population.

Data Highlights

Key Findings

• Two first-line treatment options with zanidatamab-hrii have been approved for HER2-positive gastroesophageal adenocarcinoma.
• Zanidatamab-hrii plus tislelizumab-jsgr and chemotherapy reduced the risk of disease progression or death by 35% compared to trastuzumab plus chemotherapy.
• Median progression-free survival was 12.4 months with zanidatamab-containing regimens versus 8.1 months with trastuzumab.
• In the overall HER2-positive population, zanidatamab-hrii plus tislelizumab-jsgr reduced the risk of death by 28% compared to trastuzumab.
• Serious adverse reactions occurred in 59% of patients receiving zanidatamab-hrii with tislelizumab-jsgr.
• Diarrhea was the most common adverse reaction reported with zanidatamab-containing regimens.

Clinical Implications

Healthcare professionals should monitor for adverse reactions, particularly diarrhea, in patients receiving zanidatamab-hrii regimens.

Conclusion

The approval of zanidatamab-hrii-containing regimens provides new treatment options for HER2-positive gastroesophageal adenocarcinoma.

Related Resources & Content

1. FDA, FDA, 2026 -- FDA approves zanidatamab-hrii and tislelizumab-jsgr for HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma
2. MDSpire News, MDSpire News -- FDA Expands Test for Gastric and Esophageal Cancers
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6. FDA approves zanidatamab-hrii and tislelizumab-jsgr for HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma | FDA
7. Immunotherapy and Targeted Therapy for Advanced Gastroesophageal Cancer: ASCO Guideline Update | Journal of Clinical Oncology