Abstract No : Abstract: #LBA9
Indication : Esophageal Cancer, Gastroesophageal junction cancer
Intervention : Nivolumab
Company : Bristol-Myers Squibb
Technology : PD-1/PD-L1 inhibitor
794 patients were randomized (nivolumab, 532; placebo, 262). Approximately 70% of patients had adenocarcinoma and almost 60% had a pathologic lymph node status ≥ypN1 in both groups. At a pre-specified interim analysis, adjuvant nivolumab showed a statistically significant improvement in DFS vs placebo (HR 0.69 [96.4% CI 0.56 -0.86]; P = 0.0003); median DFS was doubled (22.4 vs 11.0 mo, respectively; Table). The majority of treatment-related adverse events (TRAEs) were grade 1 or 2. The frequency of serious TRAEs and TRAEs leading to discontinuation were ≤ 9% with nivolumab and 3% with placebo (Table). Data including DFS rate and an analysis of DFS across pre-specified subgroups will be presented.
Adjuvant nivolumab is the first therapeutic to provide a statistically significant and clinically meaningful improvement in DFS vs placebo and a well-tolerated safety profile in patients with resected EC/GEJC, who have received neoadjuvant CRT. These results represent the first treatment advance in many years for these patients, potentially establishing adjuvant nivolumab as a new standard of care.