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The two most common types of esophageal cancer are squamous cell carcinoma and adenocarcinoma, which account for approximately 84% and 15% of all esophageal cancers, respectively, though esophageal tumor histology can vary by region with the highest rate of esophageal adenocarcinoma occurring in North America (65%). 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.Įsophageal cancer is the seventh most common cancer and the sixth leading cause of death from cancer worldwide.
#Checkmate 577 trial#
The primary endpoint of the trial is DFS and the secondary endpoint is OS. The CheckMate -577 trial will continue as planned to allow for future analysis of the secondary endpoint of overall survival (OS).ĬheckMate -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 therapy and have not achieved a pathological complete response.
#Checkmate 577 full#
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. We plan to provide our data to health authorities worldwide with the goal of bringing Opdivo as an adjuvant therapy to these patients with high unmet need.” “The results from CheckMate -577 are immensely important for physicians and patients, and have the potential to establish Opdivo as a new standard of care. Waxman, M.D., development lead, Gastrointestinal Cancers, Bristol Myers Squibb. “ Opdivo 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,” said Ian M. For the first time, we have a potential therapeutic option with nivolumab in the adjuvant setting for these patients.” “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. Sammons Cancer Center at Baylor University Medical Center. Kelly M.D., MBA, Director of the Charles A.
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“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. This is the second tumor, in addition to melanoma, where Opdivo has demonstrated a benefit in the adjuvant setting. The safety profile of Opdivo was consistent with previously reported studies. 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. PRINCETON, NJ, USA I AugI Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 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. Second tumor, in addition to melanoma, where Opdivo has demonstrated a benefit in the adjuvant setting Opdivo is the first and only treatment to demonstrate superior efficacy in patients with esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy and resection