EU approves Opdualag for advanced (unresectable or metastatic) melanoma

The EC’s decision is based upon an exploratory analysis of results from the Phase II/III RELATIVITY-047 trial in patients with tumor cell expression < 1%, which demonstrated that treatment with the fixed-dose combination of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab more than doubled the median progression-free survival (PFS) compared to nivolumab monotherapy – an established standard of care. No new safety events were identified with the combination when compared to nivolumab monotherapy.

The indication in the European Union is based upon an exploratory analysis of the RELATIVITY-047 data in patients with tumor cell PD-L1 expression < 1%: Efficacy: Median PFS was 6.7 months in patients receiving Opdualag (95% Confidence Interval [CI]: 4.7 to 12.0); (Hazard Ratio [HR] 0.68 (0.53, 0.86)) compared to 3.0 months in patients receiving nivolumab monotherapy (95% CI: 2.8 to 4.5). Median overall survival in the Opdualag arm of the trial has not yet been reached (HR 0.78 (0.59, 1.04)). Safety: The most common adverse reactions were fatigue (41%), musculoskeletal pain (32%), rash (29%), arthralgia (26%), diarrhea (26%), pruritus (26%), headache (20%), nausea (19%), cough (16%), decreased appetite (16%), hypothyroidism (16%), abdominal pain (14%), vitiligo (13%), pyrexia (12%), constipation (11%), urinary tract infection (11%), dyspnea (10%), and vomiting (10%). The most common serious adverse reactions were adrenal insufficiency (1.4%), anemia (1.4%), back pain (1.1%), colitis (1.1%), diarrhea (1.1%), myocarditis (1.1%), pneumonia (1.1%), and urinary tract infection (1.1%). The incidence of Grade 3-5 adverse reactions was 43% among patients treated with Opdualag compared to 35% among patients receiving nivolumab monotherapy. The RELATIVITY-047 trial also met its primary endpoint of PFS in the all-comer population.