BMS’s Opdualag Snags Approval for Melanoma

Opdualag is a first-in-class immunotherapy that combines Opdivio with the novel LAG-3-blocking antibody relatlimab.

The FDA approved Bristol Myers Squibb’s Opdualag (nivolumab and relatlimab-rmbw), a first-in-class treatment for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.

The fixed-dose combination of nivolumab and relatlimab, administered as a single intravenous infusion, will be available immediately, a BMS spokesperson told FormularyWatch®.

The wholesale acquisition cost (WAC) for an Opdualag adult infusion is $27,389, “priced in line with other combination therapies for metastatic melanoma based on median doses or duration,” the spokesperson said.

“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,” F. Stephen Hodi, M.D., director of the Melanoma Center and the Center for Immuno-Oncology at Dana-Farber Cancer Institute, said in a news release.

Opdualog’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,” Hodi added.

The approval is based on the phase 2/3 RELATIVITY-047 trial, which compared Opdualag with Opdivo (nivolumab) alone. Opdualag more than doubled the median progression-free survival when compared with nivolumab monotherapy (10.1 months versus 4.6 months).

The combination of nivolumab (anti-PD-1) and relatlimab (anti-LAG-3) results in increased T-cell activation compared to the activity of either antibody alone, BMS said. And relatlimab (in combination with nivolumab) is the first LAG-3-blocking antibody to demonstrate a benefit in a phase 3 study.

“Today’s approval is exciting news and offers new hope to the melanoma community. The availability of this treatment combination may enable patients to potentially benefit from a new, first-in-class dual immunotherapy,” said Michael Kaplan, president and CEO of the Melanoma Research Alliance.

Opdualag’s safety profile was similar to that previously reported for Opdivo.

Opdualag is associated with several warnings and precautions, including: severe and fatal immune-mediated adverse reactions, such as pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, dermatologic adverse reactions, myocarditis and other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); and embryo-fetal toxicity.