Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 240 mg of nivolumab and 80 mg of relatlimab per 20 mL [12 mg and 4 mg per mL] in a single-dose vial) |
Drug Class | Programmed death receptor-1 (PD-1) blocking antibodies and lymphocyte activation gene-3 (LAG-3) blocking antibodies |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
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Summary
- Opdualag (nivolumab and relatlimab) is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- The combination of nivolumab/relatlimab showed no significant difference in progression-free survival (PFS) and overall response rate (ORR) compared to ipilimumab/nivolumab (PFS: HR = 0.99 [95% CI 0.75-1.31], ORR: RR = 0.99 [95% CI 0.78-1.27]).
- PD-(L)1/BRAF/MEK inhibitors triplet combinations demonstrated superior effectiveness in PFS (HR = 0.56 [95% CI 0.37-0.84]) and ORR (RR = 3.07 [95% CI 1.61-5.85]) compared to ipilimumab/nivolumab.
- Nivolumab/relatlimab was ranked third in efficacy among the regimens compared, following nivolumab 1 mg/kg plus ipilimumab 3 mg/kg and nivolumab 3 mg/kg plus ipilimumab 1 mg/kg.
- Relatlimab/nivolumab demonstrated a trend towards a lower risk of grade ≥3 treatment-related adverse events (TRAEs) compared to ipilimumab/nivolumab (RR = 0.71 [95% CI 0.30-1.67]).
- Ipilimumab/nivolumab had the highest risk of developing grade ≥3 TRAEs, while relatlimab/nivolumab trended towards a better safety profile compared to ipilimumab/nivolumab, although specific comparative data were not provided for three other regimens.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Opdualag (nivolumab and relatlimab) Prescribing Information. | 2022 | Bristol-Myers Squibb Company Princeton, NJ |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Activity and safety of first-line treatments for advanced melanoma: A network meta-analysis. | 2023 | European Journal of Cancer |
Comparative efficacy and safety of immune checkpoint inhibitors for unresectable advanced melanoma: A systematic review and network meta-analysis. | 2023 | International Immunopharmacology |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Systemic Therapy for Melanoma: ASCO Guideline Update. | 2023 | Journal Of Clinical Oncology |