Opdualag
Unresectable or metastatic melanoma in adults and pediatric patients 12 years of age or older weighing at least 40 kg.
Adults and pediatric (≥40 kg): 480 mg nivolumab / 160 mg relatlimab IV over 30 minutes every 4 weeks
Until disease progression or unacceptable toxicity
Injection: 240 mg nivolumab and 80 mg relatlimab per 20 mL (12 mg and 4 mg per mL) single-dose vial
None listed.
- Immune-Mediated Adverse Reactions: Pneumonitis (3.7%), colitis (3.4%), hepatitis (6.4% — Grade 3-4 in 2.4%), endocrinopathies (hypothyroidism 13.7%, hyperthyroidism 4.2%, adrenal insufficiency 3.4%, hypophysitis 2.0%), nephritis (1.5%), skin reactions (4.7%), myocarditis (1.7%).
- Infusion-Related Reactions: In 6.6%.
- Embryo-Fetal Toxicity
Musculoskeletal pain (45%), fatigue (39%), rash (28%), pruritus (25%), diarrhea (24%), headache (18%), hepatitis/transaminase elevation (19%), hypothyroidism (14%), nausea (14%), vitiligo (11%), cough (11%)
Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.
Opdualag combines two immune checkpoint inhibitors: nivolumab (human IgG4 anti-PD-1 antibody) and relatlimab (human IgG4 anti-LAG-3 antibody). LAG-3 (lymphocyte-activation gene 3) is an inhibitory receptor expressed on activated T cells that binds MHC class II molecules and negatively regulates T-cell proliferation and cytokine production. Dual blockade of PD-1 and LAG-3 provides synergistic restoration of T-cell function compared to PD-1 blockade alone, as these pathways represent non-redundant immune checkpoints.
Nivolumab: half-life 26.7 days, clearance 9.5 mL/h. Relatlimab: half-life 25.3 days, clearance 7.9 mL/h. Steady-state for both by ~12 weeks. Linear PK for both components.
Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.
- RELATIVITY-047 — Nivolumab + relatlimab vs. nivolumab alone in untreated advanced melanoma. Phase II/III, n=714.