EC Authorizes Opdualag From BMS As A Melanoma Treatment

The fixed-dose combination Opdualag (nivolumab and relatlimab) from Bristol Myers Squibb (BMS) has received clearance from the European Commission for use as the first-line therapy for advanced unresectable or metastatic melanoma.

Patients aged 12 years and older who have cancer cells that express less than 1% PD-L1 are eligible for treatment. An exploratory analysis of the results from the multinational, double-blind, randomised Phase II/III RELATIVITY-047 clinical trial served as the foundation for this approval.

The trial data shows that Opdualag medication significantly improved median progression-free survival (PFS) compared to nivolumab monotherapy, a proven standard of care.

PFS in the all-comer group was the study’s primary endpoint, which was achieved.

In the Opdualag arm, the median PFS was 6.7 months as opposed to three months in the nivolumab monotherapy group. Furthermore, compared to nivolumab monotherapy, no new adverse events related to the combination therapy were reported.

The experiment revealed that tiredness, muscle problems, rash, arthralgia, diarrhoea, and pruritus were the most frequently reported side effects.

Opdualag is now legal to use in all EU member states as well as in Norway, Iceland, and Liechtenstein.

Nivolumab and relatlimab are combined in Opdualag at a set dose. Relativelimab is a brand-new LAG-3-blocking antibody, whereas Nivolumab is a PD-1 inhibitor. Samit Hirawat, executive vice president and chief medical officer of Bristol Myers Squibb Global Drug Development, stated that Opdualag is currently the first licenced LAG-3-blocking antibody combination for metastatic melanoma in the European Union.

The substantial advantage of suppressing both LAG-3 and PD-L1 with our new immunotherapy combination was clearly shown by the RELATIVITY-047 research. Following the company’s approval of Sotyktu (deucravacitinib) for the treatment of people with moderate-to-severe plaque psoriasis, the most recent advancement has occurred.