Nivolumab and relatlimab

(Opdualag®)

Nivolumab and relatlimab

Drug updated on 9/4/2024

Dosage FormInjection (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 ClassProgrammed 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
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  • 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 TitleYearSource
Opdualag (nivolumab and relatlimab) Prescribing Information. 2022Bristol-Myers Squibb Company Princeton, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
Systemic Therapy for Melanoma: ASCO Guideline Update.2023Journal Of Clinical Oncology