NICE have approved dabrafenib plus trametinib as an option for the adjuvant treatment of resected stage III BRAF V600 mutation-positive melanoma in adults.
There are currently no adjuvant treatments available for stage III BRAF V600 mutation-positive melanoma and there is a substantial risk of the cancer returning and becoming incurable.
“There are currently no adjuvant treatments available for people with stage III BRAF V600 mutation-positive melanoma, a disease which can cause severe and debilitating symptoms,” explained Mirella Marlow, deputy director for the NICE Centre for Health Technology Evaluation.
“We are therefore delighted that we were able to work with the company and NHS England to recommend dabrafenib plus trametinib as a new treatment option, marking an important development in the management of melanoma,” Marlow added.
Clinical evidence for the recommendation came from the COMBI-AD trial, which is a double-blind randomized placebo-controlled trial. Data from this study led the NICE committee to concluded that dabrafenib with trametinib increases relapse-free survival.
Median overall survival was not reached in either arm of the trial, suggesting that more than 50% of patients were still alive at the time of data cut-off. However, the hazard ratio for death was 0.57 for dabrafenib with trametinib compared with placebo.
The committee considered that the results, although immature, were extremely promising and, together with the evidence from the clinical experts, strongly suggest that combination adjuvant treatment with dabrafenib with trametinib will increase overall survival.
According to company estimates 427 individuals will be eligible for this treatment. Both drugs are taken orally, dabrafenib twice daily and trametinib once daily. The treatment will be available at a confidential discounted price agreed between NHS England and the company.
Current treatment is routine surveillance, which includes regular check-ups and surveillance imaging.