Immune Checkpoint Therapy Combination Approved for Advanced Melanoma  

The FDA approved nivolumab and relatlimab-rmbw (Opdualag) for some patients with advanced melanoma   

The U.S. Food and Drug Administration (FDA) has approved a combination of the checkpoint inhibitors nivolumab and relatlimab-rmbw (Opdualag) for the treatment of adult patients with melanoma that cannot be surgically removed or that has metastasized. 

Immune checkpoint inhibitors are immunotherapy drugs that block the activity of checkpoint proteins that dampen the immune response against cancer cells. Nivolumab (Opdivo) and relatlimab block the PD-1 and LAG-3 checkpoint proteins, respectively. By inhibiting these proteins, this combination can enhance the body’s anticancer immune response.  

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The approval was based on the results of a randomized, double-blinded clinical trial of 714 patients with previously untreated metastatic or unresectable melanoma. The trial compared the nivolumab and relatlimab-rmbw combination with nivolumab alone, which is the standard of care for this patient population. Study participants received their respective therapies by intravenous infusion every four weeks until disease progression or unacceptable toxicity.  

The trial demonstrated a significant improvement in progression-free survival in patients treated with the combination therapy (10.1 months) compared with those treated with nivolumab alone (4.6 months).  

Melanoma is a rare, but aggressive, form of skin cancer. According to federal statistics, more than 99,700 melanoma cases are expected to be diagnosed in the U.S. in 2022.   

The FDA decision was rendered on March 18, 2022.