Nivolumab and relatlimab-rmbw

(Opdualag®)

Opdualag®

Drug updated on 10/24/2024

Dosage FormInjection (intravenous; 240 mg of nivolumab and 80 mg of relatlimab per 20 mL [12 mg and 4 mg per mL])
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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  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • The combination of relatlimab/nivolumab and ipilimumab/nivolumab exhibited comparable effectiveness for progression-free survival (PFS) with a hazard ratio of 0.99 (95% Confidence Interval (CI) 0.75-1.31) and for overall response rate (RR) with a relative risk of 0.99 (95% CI 0.78-1.27).
  • For patients with BRAF-mutant melanoma, the PD-(L)1/BRAF/MEK inhibitors triplet combination demonstrated superior 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 suggested as a treatment for patients with unresectable or metastatic cutaneous melanoma, regardless of BRAF mutation status, broadening its applicability to a wider patient population.
  • The combination of relatlimab/nivolumab was associated with a lower risk of grade ≥3 treatment-related adverse events (TRAEs) compared to ipilimumab/nivolumab (RR = 0.71, 95% CI 0.30-1.67), though the risk was still higher than monotherapy.
  • Relatlimab/nivolumab had a lower but still notable risk of severe dermatologic immune-related adverse events (irAEs) compared to ipilimumab/nivolumab, which was associated with the highest toxicity for grade ≥3 TRAEs.
  • There is no population types or subgroups information available in the reviewed documents.

Product Monograph / Prescribing Information

Document TitleYearSource
Opdualag (nivolumab and relatlimab-rmbw) Prescribing Information.2024Bristol-Myers Squibb Company Princeton, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
Systemic Therapy for Melanoma: ASCO Guideline Update2023Journal of Clinical Oncology