CHMP Recommends Approval for Bristol Myers Squibb First-Line Treatment for Advanced Melanoma

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of Bristol Myers Squibb’s fixed-dose combination of nivolumab and relatlimab for the first-line treatment of advanced melanoma. The European Commission will now review CHMP’s recommendation for approval.

Development of Bristol’s Fixed-Dose Combination

Recently, Bristol Myers Squibb submitted a treatment for patients with advanced melanoma. The treatment is a mixture, otherwise known as a fixed-dose combination, of the drugs nivolumab and relatlimab, both designed to combat cancer.

The patients eligible for the treatment are those whose cancer is unresectable or metastatic with tumor cell PD-L1 expression < 1%. PD-L1 is a protein which assists in preventing immune cells from attacking non harmful body cells. Having an expression of < 1% in this protein means that the patient’s cells will likely be more responsive to therapy. Opdualag is the first-line treatment for these patient’s advanced melanoma. In addition, it serves as a LAG-3 blocking antibody, which leads to a better immune response that induces tumor cell death. 

Related article: Novavax Requires Extra Warnings One Day After Receiving Emergency Use Authorization 

The RELATIVITY-047 Trial Proved Treatment to Work

RELATIVITY-047 is a global, double blind trial designed to compare the results of the fixed-dose combination of nivolumab and relatlimab against nivolumab monotherapy – an established standard of care for cancer patients. 

The results from the Phase ⅔ RELATIVITY-047 trial demonstrated that the treatment had double the median progression free survival in patients than nivolumab monotherapy; this number included patients with tumor cell PD-L1 expression < 1%. 

As a result of this data, CHMP gave a positive recommendation for the EC to approve of the use of the fixed-dose combination of nivolumab and relatlimab in the European Union (EU). Should the EC approve of its usage, Opdualag will become the first LAG-3 blocking antibody combination in Europe.

In addition to thanking those who participated in the RELATIVITY-047 trial, Bristol Myers Squibb published a news release in which the development lead of relatlima, Paul Basciano, said “This positive CHMP opinion marks the first step toward the potential approval of the first LAG-3 blocking antibody combination – and the third distinct checkpoint inhibitor for BMS – for advanced melanoma patients in the EU.”

The U.S. Food and Drug Administration (FDA) approved the fixed-dose combination of nivolumab and relatlimab on March 18th. With the data gleaned from the RELATIVITY-047 trial, CHMP gave this treatment a positive recommendation to the EC, who will now review their opinion for approval.

Author

Max Heirich