Bristol Myers Squibb today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction (GEJ) cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (CRT). The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.

“For many patients with localized esophageal or gastroesophageal junction cancer, the risk of recurrence is high, even after neoadjuvant chemoradiotherapy and surgery. This leaves patients in need of additional treatment options,” said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb. “We believe that the use of immunotherapy in earlier stages of cancer is important because of its potential to prevent recurrence. The CHMP’s positive recommendation for Opdivo as an adjuvant treatment for esophageal or gastroesophageal junction cancer represents a step forward for people living with these cancers as we see the science translate into outcomes.”

The positive opinion is based on results from the Phase 3 CheckMate -577 trial which showed that treatment with Opdivo following neoadjuvant CRT and complete surgical resection doubled the primary endpoint of disease-free survival (DFS) compared to placebo in the all-randomized population. The safety profile of Opdivo was consistent with previously reported studies. Results from CheckMate -577 were presented at the 2020 European Society for Medical Oncology (ESMO) Virtual Congress in September 2020 and at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2021.

Opdivo is approved in the United States for the adjuvant treatment of completely resected esophageal or GEJ cancer with residual pathologic disease in patients who have received neoadjuvant CRT.

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -577 trial.