Drug updated on 4/18/2024
| 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.
Summary
- Nivolumab and relatlimab (Opdualag) are indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. They exhibit similar progression-free survival (PFS) and overall response rate (ORR) compared to the combination of ipilimumab and nivolumab but tends to have a better safety profile concerning severe treatment-related adverse events.
- Two studies were reviewed to gather information about Opdualag's effectiveness and safety.
- The studies suggest that PD-(L)1/BRAF/MEK inhibitors may be superior in terms of both PFS and ORR, potentially positioning these regimens above Opdualag in BRAF-mutant patient populations. However, direct comparison data between Opdualag and BRAF/MEK inhibitors were not explicitly provided.
- In comparing other immune checkpoint inhibitor (ICI) regimens, certain combinations involving nivolumab had higher overall survival rates than others. Meanwhile, pembrolizumab at a dose of 10 mg/kg was noted for its high efficiency as well as an improved safety profile over other ICIs, including those containing nivolumab.
- No detailed breakdowns by demographic subgroups such as age beyond the stipulation that treatments included patients aged 12 years or older were given in these studies. This suggests a need for further research into subgroup considerations.
- Overall, evidence suggests that Opdualag is competitive amongst various options available today due to its balance between efficacy against advanced melanoma alongside fewer reported instances regarding serious side effects from usage compared with alternatives like ipilimumab/nivolumab.
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 |