NICE recommends monotherapy for adjuvant treatment of stage 3 melanoma

The approval follows a successful period of monitoring and patient access through the Cancer Drugs Fund.

NICE has issued guidance recommending Merck/MSD’s Keytruda (pembrolizumab) for routine commissioning, for use as a monotherapy for the adjuvant treatment of adults with stage 3 melanoma with lymph node involvement who have undergone complete resection.

“More than 16,000 people are diagnosed with Melanoma every year. There have been huge medical advances in the field of melanoma over the last decade and immunotherapy treatment has been an integral to this,” shared Susanna Daniels, CEO of Melanoma Focus. “Fear of recurrence of cancer is also a huge emotional burden for patients and families and in particular for the growing population of melanoma patients who are diagnosed at a younger age, with the majority of their life ahead of them (in the 15 to 44-year-olds age group, melanoma is the second most common cancer in males and the third most common in females).”

Prior to adjuvant therapy being an available option for some patients, standard post-surgical practice in melanoma was active surveillance, closely monitoring a patient to check for cancer recurrence. Stage 3 patients are at increased risk of this recurrence. According to the phase 3 EORTC1325/KEYNOTE-054 trial which this approval is based off, more than three quarters of these patients will not have had recurrence of their cancer within a year of initial treatment.

There are roughly 16,7000 new melanoma skin cancer cases every year in the UK, making it one of the country’s most prevalent cancers. Around 7% of patients are diagnosed at Stage 3, and five-year survival estimates for this stage of disease are at roughly 50-55%. Those with fully resected stage 3 melanoma are at high risk of disease recurrence, with five-year relapse-free survival sitting at 28-44%.

Daniels added: “I am delighted for patients that NICE have recognised the value this treatment adds for people with stage 3 melanoma by reducing the likelihood of recurrence, and that it will now be available on a routine basis.”