Scottish Medicines Consortium (SMC) says ‘yes’ to targeted combination therapy for both treatment-naïve and previously treated adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation

Scottish Medicines Consortium (SMC) says ‘yes’ to targeted combination therapy for both treatment-naïve and previously treated adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation

• As is the case for these patients throughout the rest of the UK, The SMC’s acceptance brings access to BRAFTOVI^® (encorafenib) plus MEKTOVI^® (binimetinib)
• Today’s acceptance boosts front-line choices and marks the first time Scottish clinicians and patients have access to effective targeted therapy in the previously treated setting too.
• Around half of melanoma patients have a mutation in the BRAF V600 gene, with these patients facing a particularly poor prognosis and higher risk of death when the cancer has spread to other parts of the body

Pierre Fabre today announced that the SMC has accepted the targeted oral combination BRAFTOVI^® (encorafenib) plus MEKTOVI^® (binimetinib) for use on the NHS in Scotland to treat adult patients with unresectable or metastatic melanoma with a mutation in the BRAF V600 gene. This acceptance means that encorafenib plus binimetinib is the first and only targeted therapy available in both treatment-naïve (untreated) and previously treated (e.g. after immunotherapy) settings in Scotland. The SMC’s acceptance comes after a resubmission.

“We are delighted with the announcement today that the SMC has approved the use of encorafenib with binimetinib in combination, for patients with advanced melanoma. This combination has been shown to extend the life of those with the BRAF mutation which is the case with around 50% of Scots with the disease,” said Leigh Smith MBE TD, Chairperson at Melanoma Action and Support Scotland (MASScot). “We are especially grateful that the SMC has not restricted the use of these drugs to either first- or second-line treatment but have left this decision to the clinicians treating the patient. This is something that MASScot has been pleading for, for a long time. This increases the treatment options for clinicians and patients - and gives hope of extending life.”

She continued: “Melanoma patients are often young working adults, frequently with dependent children or elderly parents who need their care. This will make a fantastic difference to the success rate and treatment options. This treatment will benefit many but by no means all. Like all cancer therapy it is not without side effects.”

In Scotland, more than 1,250 people were diagnosed with melanoma in 2018. Melanoma is currently the most common cancer in 15-34 years olds in Scotland. Melanoma is one of the most life-threatening types of skin cancer and is associated with low survival rates. In the twenty years between 1998-2018, the number of deaths from melanoma in Scotland has risen by a fifth (20%). In 2018, there were 173 deaths from melanoma in Scotland.

The SMC’s acceptance is based on data from the pivotal Phase 3 COLUMBUS trial. Results demonstrated that the combination of encorafenib 450 mg daily and binimetinib 45 mg twice daily improved median progression-free survival (primary endpoint) compared with vemurafenib alone 960 mg twice daily (14.9 months versus 7.3 months, respectively: hazard ratio [HR] 0.51, 95% confidence interval [CI], 0.39–0.67; p<0.001). Additionally, treatment with encorafenib in combination with binimetinib achieved a median overall survival (OS) of 33.6 months, compared with 16.9 months for patients treated with vemurafenib as a monotherapy (HR 0.61, 95% CI, 0.47–0.79; p<0.0001) in the planned OS analysis. All secondary efficacy analyses, including OS, are descriptive in nature.

The discontinuation rate due to suspected treatment-related adverse events (AEs) was shown to be lower with this targeted therapy (10%) compared to vemurafenib (14%). AEs led to discontinuation in 16% of patients receiving encorafenib in combination with binimetinib compared to 17% in patients treated with vemurafenib.

“Today’s acceptance is testament to our collaboration with the SMC and commitment to Scottish melanoma patients,” said Laura McMullin, General Manager UK & Ireland. “After a resubmission, we are pleased that our productive conversations resulted in this targeted combination being recognised as a beneficial and affordable therapy. Scottish patients now have access in line with their counterparts throughout the UK – and we are all thrilled with the result.”