The Lynx Group

Opdualag, a Novel Immunotherapy Combination, FDA Approved for Advanced Melanoma

April 2022, Vol 13, No 2

On March 18, 2022, the FDA approved the combination of 2 distinct immune checkpoint inhibitors, the new LAG-3 antibody relatlimab-rmbw (Opdualag; Bristol Myers Squibb) plus the PD-1 inhibitor nivolumab (Opdivo; Bristol Myers Squibb), for patients aged ≥12 years with unresectable or metastatic melanoma. Opdualag is a new fixed-dose combination of the 2 monoclonal antibodies, relatlimab and nivolumab.

The FDA approved this new combination therapy based on results of the RELATIVITY-047 clinical trial, a randomized, double-blind study of 714 patients with newly diagnosed metastatic or unresectable stage III or IV melanoma. The study excluded patients with active autoimmune disease requiring systemic therapy with moderate- or high-dose corticosteroids or immunosuppressive medications, uveal melanoma, or active or untreated brain or leptomeningeal metastases.

Patients were randomized in a 1:1 ratio to the combination of intravenous (IV) nivolumab 480 mg plus IV relatlimab 160 mg or to IV nivolumab 480 mg, alone, either infused every 4 weeks until disease progression or until unacceptable toxicity. The key efficacy outcome was progression-free survival using RECIST version 1.1.

The results showed a significant improvement in progression-free survival favoring relatlimab plus nivolumab versus nivolumab alone (hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.62-0.92; P = .0055). The median progression-free survival was 10.1 months (95% CI, 6.4-15.7) with relatlimab plus nivolumab versus 4.6 months (95% CI, 3.4-5.6) with nivolumab alone. The overall survival (OS) was not significantly different between the 2 arms (HR, 0.80; 95% CI, 0.64-1.01), and the median OS was not reached (NR) in the relatlimab plus nivolumab arm (95% CI, 34.2- NR) and was 34.1 months (95% CI, 25.2-NR) in the nivolumab-alone arm.

The most common (≥20%) adverse reactions seen with this monoclonal antibodies combination were musculoskeletal pain, fatigue, rash, pruritus, and diarrhea. The most common (≥20%) laboratory abnormalities were decreased hemoglobin levels, decreased lymphocytes, increased aspartate aminotransferase, increased alanine aminotransferase, and decreased sodium.

The recommended dose of relatlimab plus nivolumab for patients ≥12 years weighing ≥40 kg is IV 480 mg of nivolumab and IV 160 mg of relatlimab every 4 weeks until disease progression or unacceptable toxicity occurs. The recommended dose for patients ≤12 years weighing <40 kg has not been established.

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