Trial Evaluating Nivolumab for Patients with Esophageal Cancer Meets Primary End Point of DFS

The phase 3 CheckMate-577 trial analyzing nivolumab (Opdivo) as adjuvant therapy for the treatment of patients with resected esophageal or gastroesophageal junction cancer met its primary endpoint of disease-free survival (DFS), according to a Bristol Myers Squibb press release.

The data found that treatment with nivolumab following neoadjuvant chemoradiation therapy and complete surgical resection showed a statistically significant improvement of DFS compared to a placebo for the all-randomized populations.

“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,” Ronan J. Kelly MD, MBA, Director of the Charles A. Sammons Cancer Center at Baylor University Medical Center, said in a press release.

Kelly explained that medical oncologists have been limited in their treatment options to offer the patients of this disease who fail to demonstrate a pathological response after undergoing “neoadjuvant chemoradiation therapy followed by surgery.” The data suggests nivolumab is a potential therapeutic option for patients with this disease.

The CheckMate-577 is a phase 3 randomized, multi-center, double-blind study evaluating the use of nivolumab as adjuvant therapy. The primary endpoint was DFS, with a secondary endpoint of overall survival. Patients were randomized to receive placebo every 2 weeks for 16 weeks followed by nivolumab every 4 weeks until disease progression.

Nivolumab’s safety profile was consistent with previously reported studies, and this is only the second tumor in which nivolumab has demonstrated a benefit in the adjuvant setting.

“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. Waxman, MD, development lead, Gastrointestinal Cancers, Bristol Myers Squibb.

Bristol Myers Squibb plans to complete a full evaluation of the available data from the CheckMate-577 trial, while also working to share the results at an upcoming medical conference. In the meantime, the trial will continue as planned for further evaluation of the secondary endpoint of overall survival.

Esophageal cancer is the seventh most common cancer and sixth leading cause of cancer deaths across the world, according to the press release. Squamous cell carcinoma accounts for 84% of all esophageal cancer cases, although the histology can vary by region. Most cases are diagnosed in the advanced stage of disease.

“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,” said Waxman. “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.”

Reference:

CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival [news release]. Princeton, New Jersey. Published August 11, 2020. https://news.bms.com/press-release/corporatefinancial-news/checkmate-577-phase-3-trial-evaluating-opdivo-nivolumab-adjuva. Accessed August 11, 2020.