Relatlimab Plus Nivolumab Approved in Europe for Unresectable or Metastatic Melanoma with PD-L1 <1%
Source: Onc Live, September 2022
The European Commission has approved the fixed-dose combination of relatlimab plus nivolumab (Opdivo; Opdualag) for use in the frontline treatment of adult and adolescent patients aged 12 years of age and older with advanced or metastatic melanoma and a PD-L1 expression of less than 1% on tumor cells.
The regulatory decision was supported by data from an exploratory analysis of the phase 2/3 RELATIVITY-047 trial (NCT03470922), in which the regimen resulted in a median progression-free survival (PFS) that was more than double that achieved with single-agent nivolumab in this patient population. The median PFS in the investigative arm was 6.7 months (95% CI, 4.7-12.0) vs 3.0 months (95% CI, 2.8-4.5) in the control arm (HR, 0.68; 95% CI, 0.52-0.86).
Moreover, the median overall survival (OS) in those who received relatlimab plus nivolumab has not been reached (HR, 0.78; 95% CI, 0.59-1.04).