Is Opdualag Approved for Advanced Melanoma?
Yes, Opdualag (nivolumab and relatlimab-rmbw) is FDA-approved to treat unresectable or metastatic (advanced) melanoma in adults and children aged 12 years and older weighing at least 40 kg. The approval came in March 2022 based on the RELATIVITY-047 phase 3 trial, which showed the combination reduced progression risk by 22% compared to nivolumab alone (median progression-free survival of 10.1 months vs. 4.6 months).[1][2]
How Does Opdualag Work Against Melanoma?
Opdualag combines nivolumab, a PD-1 inhibitor, with relatlimab, a LAG-3 inhibitor. These block immune checkpoints that tumors use to evade T-cell attacks, enhancing the body's response against melanoma cells. In advanced cases, where surgery isn't possible, this dual blockade targets melanoma's high mutation burden, which makes it responsive to immunotherapy.[1][3]
Who Qualifies for Opdualag Treatment?
It's indicated as first-line therapy for unresectable or metastatic melanoma, regardless of BRAF mutation status. Patients must be adults or adolescents (12+ years, ≥40 kg). It's administered intravenously every 4 weeks (480 mg nivolumab + 160 mg relatlimab).[1][2] No prior systemic therapy is required, unlike some checkpoint inhibitors.
How Does It Compare to Other Melanoma Treatments?
Opdualag outperformed single-agent Opdivo (nivolumab) in RELATIVITY-047, with better progression-free survival but similar overall survival data so far (ongoing follow-up).[3] Compared to:
- Keytruda (pembrolizumab): Similar PD-1 mechanism; Keytruda has broader approvals but no head-to-head data. Progression-free survival in KEYNOTE-006 was 5.5 months monotherapy.[4]
- Yervoy (ipilimumab) + Opdivo: CheckMate 067 showed 11.5 months progression-free survival, but higher toxicity (55% grade 3/4 adverse events vs. Opdualag's 19%).[3][5]
Opdualag offers a tolerable dual-immunotherapy option without chemotherapy.
| Treatment | Median PFS (months) | Grade 3/4 AEs (%) | Key Trial |
|-----------|---------------------|-------------------|-----------|
| Opdualag | 10.1 | 19 | RELATIVITY-047 |
| Opdivo alone | 4.6 | 14 | RELATIVITY-047 |
| Opdivo + Yervoy | 11.5 | 55 | CheckMate 067 |
| Keytruda alone | 5.5 | 13 | KEYNOTE-006 |
What Side Effects Should Patients Expect?
Common issues (≥20%) include fatigue, musculoskeletal pain, rash, pruritus, diarrhea, and nausea. Immune-related effects like hypothyroidism (17%), hepatitis, or pneumonitis occur; severe cases (grade 3/4) hit 18.9%. Monitor thyroid and liver function; discontinue if needed.[1][2] Patient reports note manageable fatigue compared to ipilimumab combos.
Ongoing Trials and Future Uses in Melanoma?
RELATIVITY-098 tests Opdualag with bempegaldesleukin in first-line advanced melanoma. It's also in trials for adjuvant therapy post-resection (RELATIVITY-098) and combinations with targeted therapies.[6] No data yet on brain metastases specifically, though nivolumab has activity there.
Cost and Access Details
List price is about $32,000 per dose (every 4 weeks), or $400,000+ annually, similar to other dual immunotherapies. Patient assistance via BMS Access Support covers copays for eligible uninsured/underinsured.[7] Medicare Part B covers it post-approval.
Sources
[1]: FDA Label for Opdualag
[2]: BMS Press Release on Approval
[3]: NEJM: RELATIVITY-047 Results
[4]: KEYNOTE-006 NEJM
[5]: CheckMate 067 Update
[6]: ClinicalTrials.gov Search for Relatlimab Melanoma
[7]: BMS Pricing and Access