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).
“[Nivolumab with relatlimab] is now the first approved LAG-3-blocking antibody combination for advanced melanoma in the European Union,” Samit Hirawat, MD, the executive vice president and chief medical officer at Bristol Myers Squibb, said in a press release. “The RELATIVITY-047 study demonstrated the important benefit of inhibiting both LAG-3 and PD-L1 with our novel immunotherapy combination. This is a continuation of our work in bringing innovative medicines to adults and adolescents living with melanoma.”
Frequent adverse effects (AEs) included fatigue (41%), musculoskeletal pain (32%), rash (29%), and arthralgia (26%). Additionally, common serious AEs included adrenal insufficiency (1.41%), anemia (1.4%), back pain (1.1%), colitis (1.1%), and diarrhea (1.1%).
The nivolumab and relatlimab combination was previously approved by the FDA for the treatment of unresectable or metastatic melanoma in March 2022 based on findings from the phase 2/3 RELATIVITY-047 trial.2