Bristol Myers' Opdualag adds EU to its market approvals

Following approval from the US regulator in March this year, on Friday Bristol Myers Squibb (NYSE: BMS) revealed that the European Commission has also cleared its fixed-dose combination of Opdualag (nivolumab and relatlimab) for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumor cell PD-L1 expression < 1%.

The EC’s decision is based on an exploratory analysis of results from the Phase II/III RELATIVITY-047 trial in patients with tumor cell expression <1%, which demonstrated that treatment with the fixed-dose combination of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab more than doubled the median progression-free survival (PFS) compared to nivolumab monotherapy – an established standard of care. No new safety events were identified with the combination when compared to nivolumab monotherapy.

Nivolumab is the active ingredient of BMS’ blockbuster cancer drug Opdivo, and Opdualag is seen by analysts as replacing Opdivo monotherapy in first-line melanoma, and capturing a significant chunk of the Opdivo/Yervoy combo’s share.