Nivolumab/Relatlimab Combo for Treatment of Unresectable or Metastatic Melanoma
Source: Cancer Network, September 2022
The European Commission based its approval of nivolumab/relatlimab for patients with a PD-L1 expression of less than 1% on the results of the phase 2/3 RELATIVITY-047 trial.
A fixed-dose combination of nivolumab and relatlimab-rmbw (Opdualag) was approved by the European Commission for treating unresectable or metastatic melanoma with tumor cell PD-L1 expression of less than 1% in adults and adolescents 12 years of age and older, according to a press release from Bristol Myers Squibb.1
The regulatory decision was supported by findings from an exploratory analysis of the phase 2/3 RELATIVITY-047 trial (NCT03470922), comparing the use of nivolumab/relatlimab vs nivolumab monotherapy. According to the trial results, nivolumab and relatlimab yielded a median progression-free survival (PFS) of 10.1 months (95% CI, 6.4-15.7) compared with 4.6 months (95% CI, 3.4-5.6) in the single-agent nivolumab arm (HR, 0.75; 95% CI, 0.62-0.92; P = .0055).