Relatlimab + nivolumab
Opdualag combines relatlimab, the first drug targeting the LAG-3 immune brake, with nivolumab for melanoma.
RELATIVITY-047: PFS 10.1 vs 4.6 months versus nivolumab alone in untreated advanced melanoma with less toxicity than ipilimumab-nivolumab. Approved 2022. Adjuvant and other tumour trials ongoing.
1.Relatlimab binds LAG-3 and nivolumab binds PD-1 on the same exhausted T cells
- Route
- IV infusion
- Schedule
- Nivolumab 480 mg + relatlimab 160 mg every 4 weeks (≥40 kg)
- Dose modifications
- As for nivolumab; hold for grade 2 immune-mediated events
- Monitoring
- Thyroid, LFTs, creatinine, glucose; adrenal function; myocarditis awareness
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
- Medicare
- Part B (clinician-administered)
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies.
- Commercial insurance
- covered with prior authorisation
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
- Assistance programmes
- BMS Access Support
- Bristol Myers Squibb Patient Assistance Foundation
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
- Appraised for
- Untreated unresectable or metastatic melanoma (PD-L1 <1%)
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA950. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- 18 Mar 2022ApprovalUS
Unresectable or metastatic melanoma, age ≥12 (RELATIVITY-047): first LAG-3 therapy source
- Sept 2022ApprovalEU
EMA approval, PD-L1 <1% melanoma source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2022 | Unresectable or metastatic melanoma, age ≥12 |
| Adverse event |
|---|
| Fatigue |
| Musculoskeletal pain |
| Rash |
| Pruritus |
| Diarrhoea |
| Hypothyroidism/thyroiditis |
| Adrenal insufficiency |
| Myocarditis (rare, monitor troponin) |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | bmsaccesssupport.com |
| United Kingdom | NICE: recommended for untreated advanced melanoma, PD-L1 <1% (2024) | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Before 2011 median survival in metastatic melanoma was under a year; this trial shows that roughly half of patients treated with combination checkpoint blockade are now long-term survivors, effectively cured. It anchors first-line treatment of advanced melanoma and sets the benchmark for every new regimen, including nivolumab-relatlimab. The combination's toxicity means nivolumab alone or newer doublets remain reasonable for some patients.
For patients with advanced melanoma, immunotherapy offers a realistic chance of long-term survival and probably cure, and the ten-year data show that patients who are alive and progression-free at three years rarely die of melanoma afterwards. Nivolumab plus ipilimumab gives the best long-term results but at a high price in serious side effects; nivolumab alone or nivolumab plus relatlimab are alternatives for patients at lower risk or with autoimmune concerns. The trial is also a caution about surrogate endpoints: the survival plateau took years to become visible.
Patients with newly diagnosed advanced melanoma have a dual-checkpoint option that improves on nivolumab alone with only a modest increase in serious side effects, making it attractive for those unable to tolerate or unwilling to risk the toxicity of ipilimumab. It did not prove superior survival, and it has not been compared with nivolumab plus ipilimumab, which remains preferred for patients with brain metastases or other high-risk features. LAG-3 is now an established target under study in many other cancers.
Latest papers
topQuery for this drug: (TITLE:"Relatlimab + nivolumab" OR ABSTRACT:"Relatlimab + nivolumab" OR TITLE:"Opdualag" OR ABSTRACT:"Opdualag") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Relatlimab + nivolumab, not a curated reading list.
Pages like this
not linked directly; found by shared links- TrialCheckMate 067
Shares RELATIVITY-047, RELATIVITY-047: relatlimab plus nivolumab, the first LAG-3 checkpoint combination, in untreated advanced melanoma, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, CheckMate 067 at ten years: half of melanoma patients treated with nivolumab plus ipilimumab were alive a decade later.
- TrialFianlimab + cemiplimab phase 3 (first-line melanoma)
Shares Caution: LAG-3 blockade outside active disease, RELATIVITY-047, LAG-3, PD-1.
- ProductFianlimab
Shares Caution: LAG-3 blockade outside active disease, LAG-3, T-cell exhaustion, Melanoma.
- TargetTIM-3
Shares LAG-3, T-cell exhaustion, PD-1 / PD-L1 immune checkpoint & T-cell activation, PD-1.
- PersonF. Stephen Hodi
Shares CheckMate 067 at ten years: half of melanoma patients treated with nivolumab plus ipilimumab were alive a decade later, CheckMate 067 at ten years: nivolumab plus ipilimumab produces long-term survival in half of patients with advanced melanoma, PD-1, Melanoma.
- TargetVISTA
Shares LAG-3, PD-1 / PD-L1 immune checkpoint & T-cell activation, PD-1, Immune checkpoint inhibitors.
- TermHallmark: avoiding immune destruction
Shares LAG-3, T-cell exhaustion, PD-1 / PD-L1 immune checkpoint & T-cell activation, PD-1.
- InstitutionDartmouth Cancer Center
Shares Bristol Myers Squibb, PD-1, Melanoma, Immune checkpoint inhibitors.