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FDA Approvals, News & UpdatesMelanoma

Opdualag a Novel Immunotherapy Combination FDA Approved for Patients with Advanced Melanoma

April 2022 Vol 8 No 2

On March 18, 2022, the FDA approved the use of a new fixed-dose combination of the PD-1 inhibitor Opdivo (nivolumab; from Bristol Myers Squibb) plus the novel LAG-3 inhibitor Opdualag (relatlimab-rmbw; from Bristol Myers Squibb), for the treatment of patients age 12 or older with unresectable (cannot be removed by surgery) or metastatic melanoma.

The FDA approved Opdualag based on the results of the RELATIVITY-047 clinical trial that included 714 patients with newly diagnosed metastatic or unresectable stage III or IV melanoma.

Patients were divided into 2 groups to receive the combination of relatlimab plus Opdivo or Opdivo alone; either drug was infused every 4 weeks until the melanoma progressed or the patient had unacceptable side effects.

The results showed a significant improvement in the time without cancer progression favoring the new immunotherapy combination Opdualag versus Opdivo alone. The average time with cancer progression was 10.1 months with the 2 immunotherapies compared with 4.6 months with Opdivo alone. The overall survival was not significantly different between the 2 groups, but the average overall survival was not reached in the Opdualag group (meaning patients were still responding to treatment) compared with 34.1 months in the Opdivo-alone group.

“These data further support the added benefit of dual checkpoint inhibition over monotherapy...and establish relatlimab–nivolumab as a potential new treatment option for patients with previously untreated metastatic or unresectable melanoma,” Dr. Tawbi and colleagues wrote in the New England Journal of Medicine.1

The most common side effects seen with the combination of the 2 checkpoint inhibitors were musculoskeletal pain, fatigue, rash, pruritus, and diarrhea. The most common laboratory abnormalities were decreased hemoglobin levels, decreased lymphocytes, increased aspartate aminotransferase, increased alanine aminotransferase, and decreased sodium.

  1. Tawbi HA, Schadendorf D, Lipson EJ, et al. Relatlimab and nivolumab versus nivolumab in untreated advanced melanoma. New England Journal of Medicine. 2022;386:24-34.

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Last modified: April 15, 2022

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