Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved the 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%.

In prespecified exploratory analyses, progression-free survival also favored relatlimab–nivolumab over nivolumab across key subgroups (Figure 2). In both treatment groups, the median progression-free survival estimates were longer for patients with LAG-3 expression of 1% or greater...Among patients with PD-L1 expression of less than 1%, the median progression-free survival with relatlimab–nivolumab was 6.4 months (95% CI, 4.6 to 11.8) as compared with 2.9 months (95% CI, 2.8 to 4.5) with nivolumab (hazard ratio, 0.66 [95% CI, 0.51 to 0.84]).

...the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Opdualag, intended for the treatment of melanoma....The benefit of Opdualag is a 3.7-month gain in progression-free survival over nivolumab monotherapy in the PD-L1 < 1% group, as observed in a randomised, double-blind, multicentre pivotal study in patients with previously untreated metastatic or unresectable melanoma.