U.S. Food and Drug Administration Accepts for Priority Review Application for Opdivo® as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer

Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) for the treatment of patients with resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting, after neoadjuvant chemoradiation therapy (CRT). The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 20, 2021. The filing was based on results from the Phase 3 CheckMate -577 trial, which is the first trial to show positive results in the adjuvant setting in this group of patients. The study met its primary endpoint of disease-free survival (DFS) in patients with esophageal or GEJ cancer, following neoadjuvant CRT and tumor resection. Results from the CheckMate -577 trial place esophageal and GEJ cancer among four tumor types – in addition to melanoma, bladder and non-small cell lung cancer – for which Opdivo has shown a benefit in the early disease setting. The safety profile of Opdivo as adjuvant therapy in the CheckMate -577 trial was consistent with that reported in previous studies. Bristol Myers Squibb thanks the patients and investigators who were involved in the CheckMate -577 clinical trial. CheckMate -577 is a Phase 3 randomized, multi-center, double-blind study evaluating Opdivo as an adjuvant therapy in patients with resected esophageal or GEJ cancer who have received neoadjuvant CRT and have not achieved a pathological complete response. The primary endpoint of the trial is DFS and the secondary endpoint is overall survival (OS). Following neoadjuvant CRT and complete tumor surgical resection (also known as trimodality therapy), a total of 794 patients were randomized to receive placebo (n=262) or Opdivo (n=532) 240 mg by intravenous infusion every two weeks for 16 weeks followed by placebo or Opdivo 480 mg every four weeks until disease recurrence, unacceptable toxicity or withdrawal of consent, with a maximum of one year total treatment duration. Follow up for OS is ongoing.