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Indication

Opdualag™ was evaluated in
a global, randomized phase 2/3
trial vs nivolumab monotherapy1

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Relativity-047: First phase 2/3 trial confirming the benefits of anti–LAG-3 therapy in combination with the PD-1 inhibitor, nivolumab1

Patient population (N=714)

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Relativity-047 study design, graph

Median duration of treatment for Opdualag at the 33.8-month median follow-up was 8.3 months.2 Treat until disease progression or unacceptable toxicity.1

Inclusion criteria1,3:

  • Histologically confirmed unresectable stage III or stage IV melanoma
  • Expression of LAG-3 and PD-L1 that could be evaluated in tumor tissue

Exclusion criteria1:

  • Patients with active autoimmune disease
  • Medical conditions requiring systemic treatment with moderate- or high-dose corticosteroids or immunosuppressive medications
  • Patients with uveal melanoma
  • Patients with active or untreated brain or leptomeningeal metastases

*Patients were allowed to receive prior adjuvant and neoadjuvant melanoma therapy. Anti–PD-1, anti–CTLA-4, or BRAF-MEK was allowed as long as there was at least 6 months between the last dose of therapy and date of recurrence; interferon therapy was allowed as long as the last dose was at least 6 weeks prior to randomization.1 PD-L1 expression (≥1% vs <1%) using PD-L1 IHC 28-8 pharmDx test.1 LAG-3 expression (≥1% vs <1%) using a clinical trial assay.1 §The final analysis of OS was not statistically significant.1

AJCC=American Joint Committee on Cancer; BICR=blinded independent central review; BRAF=B-Raf proto-oncogene; CTLA-4=cytotoxic T-lymphocyte associated antigen 4; ECOG PS=Eastern Cooperative Oncology Group Performance Status; IHC=immunohistochemistry; IV=intravenous; LAG-3=lymphocyte-activation gene-3; M=metastases; MEK=mitogen-activated extracellular signal-regulated kinase; ORR=overall response rate; OS=overall survival; PD-1=programmed cell death protein-1; PD-L1=programmed death-ligand 1; PFS=progression-free survival; Q4W=every 4 weeks; RECIST=Response Evaluation Criteria in Solid Tumors.

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Efficacy Data

Explore the 33.8-month median follow-up data from the clinical trial.

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Safety Data

Find information about adverse reactions seen in the clinical trial.

References:

  1. Opdualag [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.
  2. Data on file. BMS-REF-Rela-0014. Princeton, NJ. Bristol-Myers Squibb Company; 2024.
  3. Tawbi HA, Schadendorf D, Lipson EJ, et al. Relatlimab and nivolumab versus nivolumab in untreated advanced melanoma. N Engl J Med. 2022;386(1):24-34.