Bristol Myers Squibb’s Opdualag approved by SMC for advanced melanoma
10 Jul 2024
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Source: PMLiVE
Bristol Myers Squibb (BMS) has announced that its new immunotherapy combination, Opdualag (nivolumab-relatlimab), has been accepted by the Scottish Medicines Consortium (SMC) for use within NHS Scotland for advanced melanoma.
Providing an additional treatment option for eligible patients in Scotland living with the form of skin cancer, the first approved LAG-3 blocking antibody combination is indicated as a first-line treatment in adults and adolescents 12 years of age and older living with the disease.
Currently the fifth-most common cancer in the UK, melanoma is a type of skin cancer that develops when pigment-producing cells located in the skin grow uncontrollably.
The condition affects more than 1,200 people in Scotland every year and approximately 10% of all cases in the UK are diagnosed at more advanced stages, leading to poorer outcomes.
The SMC’s decision was based on results from the phase 2/3 RELATIVITY-047 trial, which has been evaluating Opdualag compared to nivolumab alone in 714 patients with previously untreated metastatic or unresectable stage 3 or 4 melanoma.
The trial achieved its primary endpoint after the combinative immunotherapy more than doubled median progression-free survival after a median follow-up of 19.3 months, compared to nivolumab monotherapy.
Commenting on the decision, Guy Oliver, general manager, BMS UK and Ireland, said: “We are proud that the [Opdualag] combination… is now a treatment option for eligible adults and adolescents living with advanced melanoma in Scotland.
“Results from the RELATIVITY-047 study demonstrated the clinical impact of this novel combination treatment, representing our ongoing commitment to helping improve patient outcomes in melanoma and bring immunotherapy to more patients.”
Already approved via the Project Orbis programme, coordinated by the US Food and Drug Administration, the Medicines and Healthcare products Regulatory Agency, and other regulatory bodies to review and approve cancer treatments that have been licenced in collaboration with other regulators, Opdualag is designed to harness the body’s own immune system to help restore its anti-tumour immune response.
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