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SMC Accepts MSD’s KEYTRUDA®▼ (pembrolizumab) for Use Within NHS Scotland as Monotherapy for the Adjuvant Treatment of Adults with Stage III Melanoma with Lymph Node Involvement Who Have Undergone Complete Resection[i]


Treatment of Scottish Patients Now Aligned with the Rest of the UK with Pembrolizumab for the Treatment of Stage III Melanoma with Lymph Node Involvement Who Have Undergone Complete Resection


HODDESDON, 13th May, 2019 - Today, MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA (NYSE: MRK)) is proud to announce that the Scottish Medicines Consortium (SMC) has accepted KEYTRUDA® (pembrolizumab) as monotherapy for the adjuvant treatment of adults with stage III melanoma with lymph node involvement who have undergone complete resection.1 The decision means that patients with stage III melanoma in Scotland will now be able to access pembrolizumab via NHS Scotland, aligning access with patients in England and Wales, where pembrolizumab was made available in December 2018.[ii]


This approval signifies an important milestone for Scottish patients with stage III melanoma where the current standard of care is routine surveillance (‘watch and wait’),[iii] and marks the sixth SMC approval for pembrolizumab, further broadening access for Scottish patients across a number of cancer types.[iv]-[v][vi][vii][viii]


Dr Ashita Waterston, Consultant Medical Oncologist, Beatson West of Scotland Cancer Centre, said: “Historically, after surgery, patients with stage III melanoma have been placed on routine surveillance, so called ‘watch and wait’ to monitor if their cancer returns. Great advances have been made in the treatment of advanced melanoma however in this setting there remains a proportion of patients who do not benefit. 

The incidences of the disease across all stages, sadly continue to increase across Scotland. This decision, therefore, offers patients a treatment option in treating melanoma alongside surgery, potentially improving outcomes by reducing risk of their disease recurring.”


Data from the EORTC1325/KEYNOTE-054 trial, published in the New England Journal of Medicine in 2018, supported the approval of pembrolizumab in the adjuvant setting for melanoma. At median follow-up of 15 months, pembrolizumab significantly reduced risk of a patients cancer returning (recurrence-free survival or RFS) than placebo (1-year rate of recurrence-free survival in the overall intention-to-treat population – 75.4% vs. 61.0% (HR = 0.57 (p<0.001)) – and in a subgroup of patients with PD-L1-positive tumours – 77.1% vs. 62.6% (HR = 0.54 (p<0.001)).[ix]


Gill Nuttall, CEO and Founder, Melanoma UK said, “In Scotland, melanoma is fast becoming one of the most common forms of cancer, where we have seen a considerable rise in the number of diagnosed cases. Routine surveillance, known as ‘watch and wait’, can have a huge impact on patients’ mental wellbeing, and can often leave them feeling left without an ‘active’ treatment option and concerned about the risk of their cancer returning. It is therefore great news that, from today, patients in Scotland benefit from this treatment option, in line with patients around the UK.”


Melanoma is the most dangerous type of skin cancer, due to the increased risk of cancer cells spreading to other parts of the body.[x] While stage III melanoma means that cancer cells have spread into skin, lymph vessels or lymph glands close to the melanoma, the cancer cells have not yet spread to more distant parts of the body.[xi] Once a tumour metastasises, it can become harder to treat and metastatic cancer accounts for most cancer deaths.[xii] Between 2006-2016, the incidence of malignant melanoma in Scotland increased by over 15%, with over 1,380 new cases diagnosed in 2016.[xiii]


John McNeil, Devolved Nations Director, MSD, said, “We are delighted that the SMC has recognised pembrolizumab’s value to Scottish patients with stage III melanoma and have broadened access to this patient population alongside those with advanced melanoma. We continue collaborating with the SMC on the shared aim of securing appropriate access for patients to the benefits of new cancer treatments. Today’s decision signifies the sixth acceptance of pembrolizumab by the SMC, allowing more Scottish patients access to this innovative, and potentially life-extending, treatment across a range of cancers.”

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Last Updated: 16-May-2019