Opdualag(nivolumab + relatlimab)

Oncology· 1095 cited findings· 2 source documents

What the regulatory reviews say

Opdualag (nivolumab + relatlimab) is indicated for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumor cell PD-L1 expression < 1%. The marketing authorization was recommended following an application submitted on 10 September 2021, and it was qualified as a new active substance. The recommended dose is 480 mg nivolumab and 160 mg relatlimab every 4 weeks.

Key efficacy findings from the CA224047 (RELATIVITY-047) study, which included 355 and 359 treated subjects in different arms, showed a median PFS of 10.15 months and 10.22 months, with PFS HRs of 0.85 and 0.79. The overall response rate (ORR) was 43.1% and 32.6%, with complete response (CR) rates of 16.3% and 14.2%. For comparison, the median OS for ipilimumab was 19.9 months, and for nivolumab/pembrolizumab, it was > 30 months. The 5-year survival rate for metastatic melanoma was 25%, while the 5-year OS rate for ipilimumab + nivolumab was 52%, and the 6.5-year OS rate for ipilimumab + nivolumab was 49%.

Regarding safety, the incidence of adverse events (any grade) was 97% and 94%, with grade 3-4 adverse events occurring in 40% and 33% of patients. Drug-related adverse events (any grade) were reported in 81.1% and 69.9% of patients, with grade 3-4 drug-related adverse events in 18.9% and 9.7%. Serious adverse events (SAEs) grade 3-4 were observed in 19.5% of patients, and fatigue (any grade) occurred in 29% of patients.

Key figures — cited to the source page

Median PFS (months)	10.15	Bristol-Myers Squibb Company — Opdualag EMA EPAR public asse, p.82
PFS HR	0.85	Bristol-Myers Squibb Company — Opdualag EMA EPAR public asse, p.82
ORR	43.1	Bristol-Myers Squibb Company — Opdualag EMA EPAR public asse, p.84
Incidence of adverse events (any grade)	97	Bristol-Myers Squibb Company — Opdualag EMA EPAR public asse, p.142
Incidence of grade 3-4 adverse events	40	Bristol-Myers Squibb Company — Opdualag EMA EPAR public asse, p.142
Incidence of drug-related AEs (any grade)	81.1	Bristol-Myers Squibb Company — Opdualag EMA EPAR public asse, p.142
Incidence of grade 3-4 drug-related AEs	18.9	Bristol-Myers Squibb Company — Opdualag EMA EPAR public asse, p.142
SAEs grade 3-4	19.5	Bristol-Myers Squibb Company — Opdualag EMA EPAR public asse, p.144

Source documents

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.