SMC approves Bristol Myers Squibb's Opdualag for advanced melanoma

Bristol Myers Squibb (BMS) has announced that its novel immunotherapy combination, Opdualag (nivolumab-relatlimab), has received acceptance from the Scottish Medicines Consortium (SMC) for use within NHS Scotland for the treatment of advanced melanoma. This approval provides a new treatment option for eligible patients in Scotland suffering from this aggressive form of skin cancer. Opdualag, the first approved LAG-3 blocking antibody combination, is designated as a first-line treatment for adults and adolescents aged 12 and older.

Melanoma, a type of skin cancer that originates from pigment-producing cells in the skin, is currently the fifth most common cancer in the UK. In Scotland alone, the condition affects over 1,200 individuals annually, with approximately 10% of UK cases diagnosed at more advanced stages, which leads to poorer prognoses.

The decision by the SMC was informed by findings from the phase 2/3 RELATIVITY-047 trial. The study has been assessing the efficacy of Opdualag in comparison to nivolumab alone in 714 patients with previously untreated metastatic or unresectable stage 3 or 4 melanoma. The trial reached its primary endpoint by demonstrating that the combinative immunotherapy more than doubled median progression-free survival in patients after a median follow-up period of 19.3 months, compared to nivolumab monotherapy.

Guy Oliver, the general manager for BMS UK and Ireland, expressed pride in the approval, stating: “We are proud that the [Opdualag] combination… is now a treatment option for eligible adults and adolescents living with advanced melanoma in Scotland.” He further highlighted the positive clinical outcomes from the RELATIVITY-047 study, which underscore BMS’s commitment to enhancing patient outcomes in melanoma and expanding the reach of immunotherapy.

Opdualag has already garnered approval through the Project Orbis programme, spearheaded by the US Food and Drug Administration (FDA) and involving regulatory agencies from various countries. This initiative aims to facilitate the review and approval of cancer treatments in collaboration with international regulators. Opdualag is designed to leverage the body’s immune system to help restore its anti-tumour immune response.

The SMC’s endorsement of Opdualag follows the National Institute for Health and Care Excellence (NICE) recommendation in January this year, which approved the treatment for advanced melanoma in patients aged 12 and older in England and Wales.