Bristol Myers Squibb’s (BMS) Opdualag (nivolumab-relatlimab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line treatment of advanced melanoma in patients aged 12 years and older.
The incidence of melanoma, a type of skin cancer that develops when pigment-producing cells located in the skin grow uncontrollably, has been rising steadily over the past few decades, with around 16,744 new cases of the disease diagnosed in the UK every year.
Around 10% of patients are diagnosed at stages 3 or 4, and despite melanomas usually being curable when caught early, the disease becomes more difficult to treat as it progresses.
The active ingredients in Opdualag are designed to harness the body’s own immune system to help restore its anti-tumour immune response, BMS explained.
NICE’s recommendation comes less than one month after the Medicines and Healthcare products Regulatory Agency (MHRA) approved the therapy for the same patient population through Project Orbis, a global partnership between regulatory bodies to review and approve promising cancer drugs, to help patients access treatments more quickly.
Both decisions were supported by results from the phase 2/3 RELATIVITY-047 trial of 714 patients with previously untreated metastatic or unresectable stage 3 or 4 melanoma who were randomised to receive a combination of nivolumab and relatlimab or nivolumab alone.
The combination was shown to have more than doubled median progression-free survival compared to nivolumab alone at a median follow-up of 19.3 months.
Dr Hosnieh Fathi, UK and Ireland medical director at BMS, said: “We are committed to expanding treatment options for patients with difficult-to-treat cancers, as evidenced by our nivolumab-relatlimab combination and the impact it will potentially have on the treatment landscape of advanced melanoma.
“Through collaborating in research and addressing unmet medical needs, another combination treatment option is now authorised, reimbursed and available to eligible melanoma patients in England and Wales.”
The US Food and Drug Administration also recently approved nivolumab, sold under the brand name Opdivo, for expanded melanoma use.
The October decision made the drug, which is already approved in the US for use in certain melanoma patients, the only PD-1 inhibitor indicated as an adjuvant treatment for eligible patients with stages 2B, 2C and 3, as well as stage 4 completely resected melanoma.