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
Regimen
Median PFS (months)
Median OS (months)
Risk Reduction (PFS)
Risk Reduction (OS)
Zanidatamab-hrii + Tislelizumab + Chemotherapy
12.4
26.4
35%
28%
Trastuzumab + Chemotherapy
8.1
19.2
-
-
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.
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