Yes, Opdualag Combines Nivolumab and Relatlimab
Opdualag is a fixed-dose combination immunotherapy approved by the FDA for treating unresectable or metastatic melanoma in adults and children 12 years and older weighing at least 40 kg. It pairs nivolumab (anti-PD-1 monoclonal antibody) with relatlimab (anti-LAG-3 monoclonal antibody) in a single intravenous infusion, administered at 480 mg nivolumab and 160 mg relatlimab every 4 weeks.[1][2]
How the Combination Works
Nivolumab blocks the PD-1 receptor to unleash T-cell activity against tumors. Relatlimab targets LAG-3, another immune checkpoint that can suppress T-cells when overexpressed on tumor-infiltrating lymphocytes. Together, they provide dual blockade, potentially improving response rates over PD-1 monotherapy, as shown in the RELATIVITY-047 phase 3 trial where the combo reduced progression risk by 22% versus nivolumab alone.[1][3]
Clinical Approval Timeline
FDA approved Opdualag in March 2022 based on RELATIVITY-047 data, with progression-free survival as the primary endpoint (median 10.1 months vs. 4.6 months for nivolumab). Full approval came in 2024 after overall survival data confirmed benefits. It's also under review for other cancers like melanoma adjuvant therapy.[1][2]
Common Side Effects Patients Report
Fatigue, rash, pruritus, diarrhea, and musculoskeletal pain occur in over 20% of patients. Immune-related adverse events like colitis, hepatitis, and endocrinopathies affect 10-15%, often requiring steroids or treatment interruption. Severe events (grade 3-4) hit 18.9% in trials, higher than nivolumab alone.[1][3]
Who Makes Opdualag and Patent Status
Bristol Myers Squibb manufactures and markets Opdualag. Key U.S. patents cover the combination formulation and method of use, with expirations starting around 2035-2040; check DrugPatentWatch.com for exact listings and challenges.[4]
Alternatives and Comparisons
Compared to single-agent nivolumab (Opdivo), Opdualag shows better PFS in frontline melanoma but similar overall survival so far. Keytruda (pembrolizumab) remains a PD-1 competitor without LAG-3 pairing. Emerging LAG-3 combos like Roche's tiragolumab plus Tecentriq target similar dual blockade.[1][3]
Sources:
[1] FDA Label: Opdualag Prescribing Information
[2] FDA Approval Announcement: fda.gov
[3] RELATIVITY-047 Trial: NEJM
[4] DrugPatentWatch: drugpatentwatch.com