FDA Grants Priority Review to Adjuvant Nivolumab for Resected Esophageal/GEJ Cancer

The FDA has accepted a supplemental Biologics License Application (sBLA) for nivolumab (Opdivo) as adjuvant treatment of patients with resected esophageal or gastroesophageal junction (GEJ) cancer after neoadjuvant chemoradiation therapy and granted it Priority Review, announced Bristol Myers Squibb, in a press release.

The Prescription Drug User Fee Act action date is set for May 20, 2021. The sBLA was based on findings from the phase 3 CheckMate-577 clinical trial (NCT02743494), which is the first study to demonstrate positive results in the adjuvant setting for this patient population.

“The FDA’s acceptance of our application marks important progress toward our goal of advancing treatment options for patients with esophageal or gastroesophageal junction cancer, in this case in early-stage disease,” said Ian M. Waxman, MD, development lead, gastrointestinal cancers, Bristol Myers Squibb, in a statement. “We look forward to working with the FDA to potentially bring nivolumab to these patients, who face a critical unmet need and remain at high risk for disease recurrence.”

The primary end point of disease-free survival (DFS) was met in patients with esophageal/GEJ cancer following neoadjuvant chemoradiation and tumor resection. The safety profile of adjuvant nivolumab appeared consistent with previously reported data.

The multicenter double-blind CheckMate-577 evaluated nivolumab as adjuvant treatment of patients with resected esophageal/GEJ cancer who received neoadjuvant chemoradiation but did not achieve a pathological complete response. In addition, the study also treated patients with melanoma, bladder cancer, and non–small cell lung cancer. A secondary end point of the study is overall survival, although follow-up for this end point remains ongoing.

Overall, 794 patients were randomized to receive nivolumab (n = 532) or placebo (n = 262) following neoadjuvant chemoradiation and complete tumor resection. Nivolumab was administered 240 mg by intravenous infusion every 2 weeks for 16 weeks, followed by either placebo or nivolumab 480 mg every 4 weeks until disease recurrence, unacceptable toxicity, or withdrawal of consent. The maximum total treatment duration is 1 year.

During the 2021 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, findings were presented from a subgroup analysis of this study and demonstrated that esophageal-specific and general quality of life were improved in patients with esophageal/GEJ cancer.

Nivolumab, a PD-1 immune checkpoint inhibitor, first received regulatory approval anywhere in the world in July 2014. The agent is approved in over 65 different countries, which include the United States, European Union, Japan, and China. The agent received approval in combination with ipilimumab (Yervoy) in October 2015, which was the first immune=oncology combination to receive regulatory approval for treatment of metastatic melanoma, which is currently approved in more than 50 countries, including the United States and European Union.

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_{U.S. Food and Drug Administration Accepts for Priority Review Application for Opdivo® (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer. News Release. January 20, 2021. Accessed January 20, 2021. https://bit.ly/3c0uYVl}