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Melanoma: Europe approves the association of immunotherapy and antibody

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Melanoma: Europe approves the association of immunotherapy and antibody

Immunotherapy paired with a new antibody gains European Commission approval for first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumor expression of PD- L1 <1%. This is the fixed-dose combination of nivolumab and relatlimab, a new antibody that blocks LAG-3. This was announced by Bristol Myers Squibb.

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Lo studio Relativity-047

The European Commission decision is based on an exploratory analysis of the results of the Phase 2/3 study Relativity-047 in patients with tumor expression <1%, which demonstrated that treatment with the fixed-dose combination of nivolumab, an inhibitor of PD-1, and relatlimab, a new antibody that blocks LAG-3, more than doubled median progression-free survival (PFS) compared to nivolumab monotherapy - an established standard of care. No new safety signals were identified with the combination versus nivolumab monotherapy. With this approval, the fixed-dose combination of nivolumab and relatlimab is now the first combination of nivolumab with an anti-LAG-3 antibody, relatlimab, approved in the European Union for advanced melanoma.

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The LAG-3 gene

Lymphocyte activation gene 3 (LAG-3) is a surface molecule expressed on effector and regulatory (Treg) T cells and functions by controlling T cell response, activation and growth. Preclinical studies indicate that inhibition of the LAG- 3 can restore effector function of depleted T cells and potentially promote an anti-tumor response. Initial research shows that targeting the LAG-3 pathway in combination with other potentially complementary immune pathways may prove to be a key strategy to more effectively enhance anti-tumor immune activity. Bristol Myers Squibb is evaluating relatlimab, the antibody that blocks LAG-3, in clinical trials in combination with other molecules in a wide range of cancer types.

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For whom the combination is suitable

The European Commission decision allows the use of the fixed-dose combination of nivolumab and relatlimab for the first-line treatment of adults and adolescents aged 12 years and older with advanced melanoma and tumor PD-L1 expression <1% in all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.


Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. Metastatic melanoma is the deadliest form of the disease and occurs when the cancer spreads beyond the surface of the skin to other organs. The incidence of melanoma has steadily increased over the past 30 years. In the United States, 106,110 new melanoma diagnoses and approximately 7,180 related deaths were estimated in 2021. Globally, the World Health Organization estimates that, by 2035, the incidence of melanoma will reach 424,102, with 94,308 related deaths. Melanoma is for the most part treatable when treated in the early stages; however, survival rates decline as the disease progresses.

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