The Food and Drug Administration (FDA) has approved Opdualag (nivolumab and relatlimab-rmbw) for the treatment of patients 12 years of age and older with unresectable or metastatic melanoma.

Opdualag is a fixed-dose combination of nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody. The approval was based on data from the randomized, double-blind phase 2/3 RELATIVITY-047 study (ClinicalTrials.gov Identifier: NCT03470922) which evaluated the efficacy and safety of Opdualag in 714 patients with previously untreated metastatic or unresectable Stage III or IV melanoma.

Patients were randomly assigned 1:1 to receive Opdualag (nivolumab 480mg and relatlimab 160mg) by intravenous (IV) infusion every 4 weeks (n=355) or nivolumab 480mg by IV infusion every 4 weeks (n=359) until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) using RECIST v1.1. Results showed that treatment with Opdualag achieved a statistically significant improvement in PFS compared with nivolumab (hazard ratio [HR], 0.75; 95% CI, 0.62-0.92; P =.0055). The median PFS was 10.1 months (95% CI, 6.4-15.7) in the Opdualag arm and 4.6 months (95% CI, 3.4-5.6) in the nivolumab arm. The final analysis of overall survival (secondary endpoint) was not statistically significant (HR 0.80; 95% CI, 0.64-1.01); with median OS not reached (NR) in the Opdualag arm (95% CI, 34.2-NR) and 34.1 months (95% CI, 25.2-NR) in the nivolumab arm.


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As for safety, the most common adverse reactions (incidence of at least 20%) for Opdualag are musculoskeletal pain, fatigue, rash, pruritus, and diarrhea. The most common laboratory abnormalities (incidence of at least 20%) were decreased hemoglobin, decreased lymphocytes, increased AST/ALT, and decreased sodium.

“Since the approval of the first immune checkpoint inhibitor more than 10 years ago, we’ve seen immunotherapy, alone and in combination, revolutionize the treatment of patients with advanced melanoma,” said F. Stephen Hodi, MD, director of the Melanoma Center and the Center for Immuno-Oncology at Dana-Farber Cancer Institute. “Today’s approval is particularly significant, as it introduces an entirely new combination of two immunotherapies that may act together to help improve anti-tumor response by targeting two different immune checkpoints — LAG-3 and PD-1.”

Opdualag is supplied as 240mg of nivolumab and 80mg of relatlimab per 20mL (12mg and 4mg per mL) in a single-dose vial.

References

  1. FDA approves Opdualag for unresectable or metastatic melanoma. News release. US Food and Drug Administration. March 18, 2022. Accessed March 21, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-opdualag-unresectable-or-metastatic-melanoma?utm_medium=email&utm_source=govdelivery
  2. U.S. Food and Drug Administration approves first LAG-3-blocking antibody combination, Opdualag™ (nivolumab and relatlimab-rmbw), as treatment for patients with unresectable or metastatic melanoma. News release. Bristol-Myers Squibb. March 18, 2022. Accessed March 21, 2022. https://www.businesswire.com/news/home/20220304005561/en/U.S.-Food-and-Drug-Administration-Approves-First-LAG-3-Blocking-Antibody-Combination-Opdualag%E2%84%A2-nivolumab-and-relatlimab-rmbw-as-Treatment-for-Patients-with-Unresectable-or-Metastatic-Melanoma
  3. Opdualag. Package Insert. Bristol-Myers Squibb; 2022. Accessed March 21, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761234s000lbl.pdf

This article originally appeared on MPR