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Bristol Myers Squibb’s Opdualag approved by CHMP for melanoma

If approved by the EC, Opdualag would be the first LAG-3 blocking antibody combination available in Europe

BMS building

The Committee for Medicinal Products for Human Use (CHMP) branch of the European Medicines Agency (EMA) has recommended approval of the fixed-dose of Bristol Myers Squibb’s (BMS) Opdualag – a combination of nivolumab and relatlimab – for use as a first-line treatment of advanced melanoma in adults and adolescents 12 years of age and older.

The approval is specifically for this age group of patients diagnosed with unresectable or metastatic melanoma with tumour cell PD-L1 expression < 1%.

The European Commission (EC) will now take time to review the CHMP opinion. If it progresses with EC approval, Opdualag would be the first lymphocyte-activation gene 3 (LAG-3) blocking antibody combination available in Europe.

Melanoma is a type of skin cancer distinguished by the uncontrolled growth of melanocytes – pigment-producing cells – located in the skin. It is the deadliest form of the disease, occurring when cancer spreads past the skin’s surface to other organs. The condition is often treatable when caught early, but survival rates can decrease as the disease progresses.

The rate of melanoma diagnoses has risen steadily over the last 30 years. The World Health Organization estimates that by 2035, the number of melanoma diagnoses  will reach over 424,000, with over 94,000 related deaths worldwide.

Paul Basciano, development lead, relatlimab, BMS said: “As part of our mission to deliver new medicines for patients, we have continued to develop new dual immunotherapy combinations.

“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 approval was based upon efficacy and safety data taken from the phase 2/3 RELATIVITY-047 trial. The trial results demonstrated that the fixed-dose combination of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab more than doubled median progression-free survival, compared to the standard of care nivolumab monotherapy.

Patients involved in the RELATIVITY-047 trial were enrolled regardless of their tumour cell PD-L1 expression. However, patients with active autoimmune disease, medical conditions needing systemic treatment with moderate or high dose corticosteroids or immunosuppressive medications, uveal melanoma and active or untreated brain or leptomeningeal metastases were excluded from the study.

BMS is currently assessing its LAG-3-blocking antibody, relatlimab, in clinical trials in combination with other agents in a variety of tumour categories.

Article by
Fleur Jeffries

26th July 2022

From: Regulatory

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