MRA Applauds Approval of Relatlimab + Nivolumab for the Treatment of Advanced Melanoma

The Melanoma Research Alliance (MRA) welcomed the news today that the U.S. Food & Drug Administration (FDA) has approved Opdualag™, Bristol-Myers Squibb’s new combination immunotherapy for the treatment of advanced melanoma.

“It is exciting to see a new, first in class, immunotherapy against the immune checkpoint LAG-3, be approved for the treatment of advanced melanoma,” said MRA Chief Science Officer Marc Hurlbert, PhD. “The potential therapeutic use of LAG-3 therapeutics in melanoma was identified by Drew Pardoll, MD, PhD, and colleagues, whose work was funded in part by a 2009 MRA Team Science Award. Today’s approval also marks the 15^th therapy in melanoma over the last decade – truly astonishing progress for researchers and patients alike.”

Nivolumab + relatlimab are drugs called checkpoint immunotherapies that work by releasing the brakes of the immune system, allowing it to attack cancer cells. Nivolumab, approved first in melanoma in 2014, targets the immune checkpoint PD-1, and is widely used to treat melanoma and many other cancers. Relatlimab is the first anti-LAG-3 antibody to earn FDA approval, making it the third distinct checkpoint inhibitor for the treatment of melanoma.

The FDA approval for nivolumab + relatlimab is based on results from the Phase 2/3 RELATIVITY-047 (CA224-047) trial that compared the combination of nivolumab + relatlimab against single-agent nivolumab in patients with previously untreated advanced melanoma. The trial results, published by the New England Journal of Medicine in January, found that patients receiving relatlimab-nivolumab lived for approximately 10.1 months without disease progression (PFS) compared to only 4.6 months for patients receiving nivolumab monotherapy. Side effects were more common among patients receiving the combination therapy, however, overall, it was well tolerated.

“Today’s approval is an important step forward for patients with melanoma,” said MRA President & CEO Michael Kaplan. “As an organization dedicated to advancing melanoma research, it is especially rewarding to see a LAG-3 therapy – whose use was discovered in part through work funded by MRA – now become available to patients in the clinic.”