NICE has recommended darolutamide with androgen deprivation therapy (ADT) for the treatment of hormone-relapsed non-metastatic prostate cancer.
In new guidance, NICE concludes that the treatment reflects good value for scarce NHS resources.
The decision is based on findings from the double-blind international randomised controlled ARAMIS trial comparing darolutamide plus ADT (n=955) with placebo plus ADT (n=554). Its primary endpoint was metastasis-free survival. Secondary outcomes included, among others, overall survival and time to starting cytotoxic chemotherapy.
The differences in metastasis-free survival and overall survival between the groups were considered statistically significant. The final analysis for metastasis-free survival and interim analyses for overall survival were done in September 2018. At that time, the trial was unblinded and people who had placebo could cross over to have darolutamide if their cancer had not metastasised. The final analysis of overall survival was done in November 2019.
Median survival on darolutamide plus ADT was 40.4 months vs 18.4 months on placebo plus ADT (hazard ratio [HR] 0.41; 95% CI 0.34-0.50).
At five years’ follow-up, only a small proportion of people in both arms had died. Fewer people died in the darolutamide arm than in the placebo arm. The complete data have not been published but NICE says the hazard ratio for overall survival for darolutamide plus ADT compared with placebo plus ADT and the 95% upper limit of the confidence intervals were less than one.
Clinical commissioning groups, NHS England, and local authorities are required to comply with the recommendations within three months. NHS Wales is generally expected to provide funding and resources to implement the recommendation within two months.
