CheckMate -577: Nivolumab as adjuvant therapy for patients with resected esophageal or gastroesophageal junction cancer, has met primary endpoint of disease-free survival
The phase 3 CheckMate -577 trial evaluating Nivolumab ( Opdivo ) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction ( GEJ ) cancer met its primary endpoint of disease-free survival ( DFS ) at a pre-specified interim analysis.
In the trial, treatment with Nivolumab following neoadjuvant chemoradiation therapy ( CRT ) and complete surgical resection has demonstrated a statistically significant improvement in the primary endpoint of DFS compared to placebo in the all-randomized population.
The safety profile of Nivolumab was consistent with previously reported studies.
The primary endpoint of the trial CheckMate -577 is DFS and the secondary endpoint is overall survival.
Following neoadjuvant CRT therapy and complete tumor surgical resection, patients were randomized to receive placebo or Nivolumab 240 mg by intravenous infusion every two weeks for 16 weeks followed by Nivolumab 480 mg every four weeks until disease progression or unacceptable toxicity.
Approximately 50% of patients with esophageal or gastroesophageal junction cancer who undergo neoadjuvant chemoradiation therapy followed by tumor resection will have disease recurrence within four years, and among those who do not respond completely to neoadjuvant treatment, recurrence will occur sooner.
Nivolumab is the first and only therapy to improve disease-free survival, along with a manageable safety profile, for patients with esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy and surgery. ( Xagena )
Source: BMS, 2020