NICE approve immunotherapy for adjuvant treatment of completely resected stage 3 melanoma

  • February 2021: NICE Recommends MSD’s KEYTRUDA® (pembrolizumab) for Routine Commissioning as Monotherapy for the Adjuvant Treatment of Adults with Stage III Melanoma with Lymph Node Involvement Who Have Undergone Complete Resection

The National Institute of Health and Care Excellence (NICE) has issued guidance that recommends KEYTRUDA® (pembrolizumab) for routine commissioning for use as monotherapy for the adjuvant treatment of adults with stage III melanoma with lymph node involvement who have undergone complete resection.

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

There are around 16,700 new melanoma skin cancer cases every year in the UK, making it one of the country’s most prevalent (5th) cancers. Approximately 7% of patients are diagnosed at Stage III. Five-year survival estimates are about 50% to 55% for stage III disease. People with fully resected stage III melanoma are still at high risk of disease recurrence, with 5-year relapse- free survival of 28% to 44%.

Susanna Daniels, CEO Melanoma Focus, welcomed the news: “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.

“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 in age, with the majority of their life ahead of them (in the 15-44 age group, melanoma is the second most common cancer in males and the third most common in females).

“It is a mark of how far we have come in treatment in recent years that we can now substantially improve survival and significantly reduce those fears. 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.”

Post-surgical practice in Melanoma had often been so-called “watch and wait”. This is the practice of closely monitoring a patient to check for cancer recurrence, something Stage III patients are at increased risk of. According to the EORTC1325/KEYNOTE-054 trial, more than threequarters of these patients will not have had recurrence of their cancer within a year of initial treatment.

The approval is based on data published in the New England Journal of Medicine in 2018. The data found that at median follow-up of 15 months, pembrolizumab was associated with significantly longer recurrence-free survival 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)).

MSD UK’s Executive Director for Oncology, David Long, added: “MSD is particularly proud of this achievement as Melanoma was one of the first cancers in which pembrolizumab proved effective, and we are delighted to be able to support even more patients in this setting. That NICE has approved pembrolizumab for routine commissioning in stage III Melanoma demonstrates the broad role that in can play as a backbone treatment in cancer care.”