Relatlimab Plus Nivolumab Approaches EU Approval for Advanced Melanoma With PD-L1 of <1%
Source: Onc Live, July 2022
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of the fixed-dose combination of nivolumab (Opdivo) and relatlimab (Opdualog) for the frontline treatment of adult and adolescents who are 12 years of age or older with advanced melanoma and a tumor cell PD-L1 expression of less than 1%.
The proposed indication was supported by findings from an exploratory analysis of patients with a PD-L1 expression of less than 1% who were examined in the phase 2/3 RELATIVITY-047 trial (NCT03470922).
Data presented during the 2022 ASCO Annual Meeting showed that the hazard ratio (HR) for progression-free survival (PFS) by blinded independent central review (BICR) in those with a PD-L1 expression of less than 1% (n = 209) was 0.68 (95% CI, 0.53-0.86). The HR for overall survival (OS) in this subset was 0.78 (95% CI, 0.59-1.04).