FDA approves Opdivo as adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer in patients who have received neoadjuvant chemoradiotherapy.- BMS

Bristol Myers Squibb announced that the FDA has approved Opdivo (nivolumab, injection for intravenous use) for the adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT). The approval is based on results from the Phase III CheckMate -577 trial that evaluated Opdivo (n=532) compared to placebo (n=262) in esophageal or GEJ cancer patients with residual pathologic disease following neoadjuvant CRT and complete resection. In the trial, among patients who received Opdivo, median disease-free survival (DFS) was twice as long as in those who received placebo (22.4 months [95% Confidence Interval [CI]: 16.6 to 34.0] compared to 11.0 months [95% CI: 8.3 to 14.3]).Odivo reduced the risk of disease recurrence or death by 31% compared to placebo (Hazard Ratio [HR] 0.69; 95% CI: 0.56 to 0.85; P=0.0003). In an exploratory analysis, among patients with adenocarcinoma (n=563, 70.9%), mDFS was 19.4 months (95% CI: 15.9 to 29.4) with Opdivo versus 11.1 months (95% CI: 8.3 to 16.8) with placebo (unstratified HR 0.75; 95% CI: 0.59 to 0.96), and among squamous cell carcinoma patients (n=230, 29%), mDFS was 29.7 months (95% CI: 14.4 to NE) with Opdivo versus 11.0 months (95% CI: 7.6 to 17.8) with placebo (unstratified HR 0.61; 95% CI: 0.42 to 0.88). See- Kelly RJ, Ajani JA, Kuzdzal J, et al. "Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy: first results of the CheckMate 577 study ". Poster presented at: 2020 European Society for Medical Oncology (ESMO) Virtual Congress. September 19-21, 2020. See- Kelly RJ, Ajani JA, Kuzdzal J, et al. "Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer". N Engl J Med. 2021;384:1191-203.