EMA validates Bristol Myers Squibb’s MAA for Opdivo as adjuvant treatment for esophageal or GEJ following chemoradiotherapy

Bristol Myers Squibb announced that the European Medicines Agency (EMA) validated its Marketing Authorization Application (MAA) for Opdivo (nivolumab) as an adjuvant treatment for esophageal or gastroesophageal junction (GEJ) cancer in adult patients with residual pathologic disease after neoadjuvant chemoradiotherapy (CRT) and resection. Validation of the application confirms that submission is complete, and the EMA’s centralized review process will begin.
The application is based on results from the phase 3 CheckMate -577 trial, in which Opdivo doubled median disease-free survival (DFS) - its primary endpoint – in patients with esophageal or GEJ cancer, following neoadjuvant CRT and tumor resection. The safety profile of Opdivo as adjuvant therapy in the CheckMate -577 trial was consistent with that reported in previous Opdivo studies.

“The majority of esophageal cancer patients with localized disease who are treated with both chemotherapy and surgery do not achieve complete response. Their risk of recurrence is unacceptably high and the establishment of more effective treatment options is essential,” said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb. “The EMA’s decision to validate our application represents important progress for the esophageal cancer community, and we look forward to potentially bringing Opdivo to patients in the EU who may benefit.”

Bristol Myers Squibb thanks the patients and investigators who have been involved in the CheckMate -577 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 gastroesophageal junction (GEJ) cancer who have received neoadjuvant chemoradiotherapy (CRT) and have not achieved a pathological complete response. The primary endpoint of the trial is disease-free survival (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.

Esophageal cancer is the seventh most common cancer and the sixth leading cause of death from cancer worldwide, with approximately 572,000 new cases and over 508,000 deaths in 2018. The two most common types of esophageal cancer are squamous cell carcinoma and adenocarcinoma, which account for approximately 85% and 14% 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%).

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.



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