FDA Approves Metastatic, Unresectable Melanoma Treatment

The US Food and Drug Administration (FDA) has approved Opdualag (nivolumab and relatlimab-rmbw), a fixed-dose combination of nivolumab and relatlimab, for use in patients 12 years or older with unresectable or metastatic melanoma.

Nivolumab and relatlimab-rmbw combines 480 mg of the programmed death receptor-1 blocking antibody nivolumab with 160 mg of the LAG-3-blocking antibody relatlimab.

The efficacy of nivolumab and relatlimab-rmbw was evaluated in RELATIVITY-047, a double-blinded trial in 714 patients with untreated metastatic or unresectable Stage III or IV melanoma. In this trial, patients were randomly assigned to receive Opdualag or nivolumab, 480 mg, by intravenous infusion every 4 weeks until the disease progressed or unacceptable toxicity resulted.

The results indicated statistically significant improvement in progression-free survival for nivolumab and relatlimab-rmbw compared with nivolumab (hazard ratio=0.75, 95% CI, 0.62-0.92, P=.006). Median PFS was 10.1 months (95% CI, 6.4-15.7) in the nivolumab and relatlimab-rmbw arm vs 4.6 months (95% CI, 3.4-5.6) in the nivolumab arm.

In this trial, the most common (≥20% incidence) adverse reactions to nivolumab and relatlimab-rmbw were musculoskeletal pain, fatigue, rash, pruritus, and diarrhea, and the most common (≥20% incidence) laboratory abnormalities were decreased levels of hemoglobin, lymphocytes, or sodium and increased AST or ALT levels.

The recommended dose of nivolumab and relatlimab-rmbw for patients at least 12 years old who weigh at least 40 kg is 480 mg nivolumab plus 160 mg relatlimab given intravenously every 4 weeks until the disease progresses or unacceptable toxicity results. However, the recommended dose for pediatric patients at least 12 years old who weigh <40 kg has not been established.

“This application was granted priority review, fast track designation, and orphan drug designation,” the FDA noted in the press release announcing the approval.

—Ellen Kurek

Reference:

FDA approves Opdualag for unresectable or metastatic melanoma. News release. UF Food and Drug Administration; March 21, 2022. Accessed April 18, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-opdualag-unresectable-or-metastatic-melanoma