Two New Combination Treatments for Esophageal Squamous Cell Carcinoma Are FDA Approved

The FDA has recently approved combination treatments for those diagnosed with unresectable advanced or metastatic esophageal squamous cell carcinoma. These combination treatments are nivolumab and fluoropyrimidine along with platinum-containing chemotherapy and nivolumab and ipilimumab. These approvals were based on a Phase 3 clinical trial.

Combinations with nivolumab have already received approval as a treatment for advanced gastric cancer, esophageal adenocarcinoma, and gastroesophageal junction cancer.

Phase 3 Trial

This Phase 3 clinical trial was called CheckMate -648, and it examined both nivolumab treatment combinations. Specifically, it examined these combination treatments compared to chemotherapy on its own.

The overall survival (OS) and progression-free survival (PFS) were primary endpoints for those who had PD-L1 expression of at least 1%. Overall survival and progression-free survival among the rest of the patient population were secondary endpoints.

This study found that the nivolumab-chemotherapy combination led to increased OS compared to chemotherapy on its own for both those with PD-L1 expression and those without. The same was found for the nivolumab-ipilimumab combination. Progression-free survival was only improved for those given nivolumab and chemotherapy who had PD-L1 expression.

Unfortunately, there were serious adverse events in 62% of the nivolumab and chemotherapy group, as well as 69% of those in the nivolumab-ipilimumab group. Adverse events ranged from pneumonia to pyrexia and dysphagia.

You can read more about this new approval and the trial that led to it here.

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