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Hospital Healthcare Europe
Hospital Pharmacy Europe     Newsletter          

Nivolumab-relatlimab approved by MHRA for advanced melanoma

The combined cancer treatment nivolumab-relatlimab (brand name Opdualag) has been granted marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) for advanced melanoma.

The monoclonal antibody treatment manufactured by Bristol-Myers Squibb is now approved for adults and children from the age of 12 years.

Administered via a drip over 30 minutes every four weeks in a hospital under specialist medical supervision, nivolumab-relatlimab is continued for as long as clinical benefit is observed by the doctor, or until side effects become too severe.

Nivolumab attaches to the target protein PD 1 and relatlimab to LAG-3, blocking their actions and helping to increase T-cell activity against the melanoma.

This nivolumab-relatlimab approval was granted through Project Orbis, a global partnership between the MHRA, the Therapeutics Goods Administration in Australia, Health Canada, the Health Sciences Authority in Singapore, Swissmedic, Agência Nacional de Vigilância Sanitária in Brazil and Israel’s Ministry of Health, coordinated by the US Food and Drug Administration. 

This programme reviews and approves promising cancer drugs, helping patients to access treatments more quickly.

Nivolumab-relatlimab and progression-free survival

The Project Orbis decision on nivolumab-relatlimab was based on the results of a phase 2/3 randomised, double-blind clinical trial involving 714 patients with previously untreated advanced melanoma.

Patients were given either 480 mg nivolumab with 160 mg of relatlimab, or 480mg of nivolumab alone, every four weeks.

The primary endpoint was progression-free survival as assessed by blinded independent central review.

The researchers concluded that the combined nivolumab-relatlimab treatment was more effective at slowing the progression of the disease over those given nivolumab alone.

The median progression-free survival was 10.1 months (95% confidence interval [CI], 6.4 to 15.7) with nivolumab-relatlimab as compared with 4.6 months (95% CI, 3.4 to 5.6) with nivolumab alone (hazard ratio for progression or death, 0.75 [95% CI, 0.62 to 0.92]; P=0.006 by the log-rank test).

Progression-free survival at 12 months was 47.7% (95% CI, 41.8 to 53.2) with nivolumab-relatlimab as compared with 36.0% (95% CI, 30.5 to 41.6) with nivolumab alone.

Grade 3 or 4 treatment-related adverse events occurred in 18.9% of patients in the nivolumab-relatlimab group and in 9.7% of patients in the nivolumab group.

The most common adverse events experienced with nivolumab-relatlimab were tiredness; pain in muscles, bones and joints; skin rash (sometimes with blisters) and itching; decreased appetite; headache; diarrhoea; constipation; nausea; vomiting; stomach pain; fever; cough; difficulty breathing; underactive thyroid gland; skin colour change in patches (vitiligo); urinary tract infection; and decreased number of red and white blood cells.

In September 2023, nivolumab (brand name Opdivo) was approved by the European Commission for use as a monotherapy for the adjuvant treatment of stage IIB or IIC melanoma.

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