Bristol Myers Squibb (BMS) has announced that the European Commission (EC) has approved Opdivo (nivolumab) for the adjuvant treatment of adult patients with oesophageal or gastroesophageal junction (GEJ) cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (CRT).
The EC’s decision is based on results from the Phase III CheckMate-577 trial, which demonstrated 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-randomised population. The safety profile of Opdivo was also found to be consistent with previously reported studies.
“We have demonstrated that the use of immunotherapy in earlier stages of cancer has the potential to prevent recurrence for certain patients,” said Ian M. Waxman, development lead, gastrointestinal cancers, BMS. “We are pleased to be the first to bring adjuvant therapy to patients in the EU with oesophageal or gastroesophageal junction cancers who continue to face a high unmet need.”
The EC decision enables Opdivo to be used for the adjuvant treatment of adult patients with oesophageal or GEJ cancer who have residual pathologic disease following prior neoadjuvant CRT in the 27 member states of the European Union, as well as Iceland, Liechtenstein and Norway.
Opdivo also received approval from the US Food and Drug Administration (FDA) in May 2021 for the adjuvant treatment of completely resected oesophageal or GEJ cancer with residual pathologic disease in patients who have received CRT.