CheckMate -577, a phase III trial evaluating Opdivo as adjuvant therapy for resected esophageal or gastroesophageal junction cancer, meets primary endpoint of disease-free survival.- BMS

Bristol Myers Squibb announced the Phase III CheckMate -577 trial evaluating Opdivo (nivolumab) 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 Opdivo following neoadjuvant chemoradiation therapy (CRT) and complete surgical resection demonstrated a statistically significant improvement in the primary endpoint of DFS compared to placebo in the all-randomized population. The safety profile of Opdivo was consistent with previously reported studies. This is the second tumor, in addition to melanoma, where Opdivo has demonstrated a benefit in the adjuvant setting. The company will complete a full evaluation of the available CheckMate -577 data and work with investigators to share the results at an upcoming medical conference, as well as discuss them with health authorities. The CheckMate -577 trial will continue as planned to allow for future analysis of the secondary endpoint of overall survival (OS). About CheckMate -577 : CheckMate -577 is a Phase III 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 therapy and have not achieved a pathological complete response. The primary endpoint of the trial is DFS and the secondary endpoint is OS. Following neoadjuvant CRT therapy and complete tumor surgical resection, patients were randomized to receive placebo or Opdivo 240 mg by intravenous infusion every two weeks for 16 weeks followed by Opdivo 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,” said Ronan J. Kelly M.D., MBA, Director of the Charles A. Sammons Cancer Center at Baylor University Medical Center. “Medical oncologists have had limited to no treatment options to offer esophageal cancer patients who undergo neoadjuvant chemoradiation therapy followed by surgery and fail to demonstrate a complete pathological response. For the first time, we have a potential therapeutic option with nivolumab in the adjuvant setting for these patients.”