What we presented here on ARANOTE, and as you know ARANOTE was a randomised phase III study looking at darolutamide plus ADT versus placebo plus ADT which met its primary endpoint of reducing radiographic progression and this was published already. So what we are looking at here is the question of these patients that are on average over 70 years old, the impact of comorbid conditions and comedications. What was very reassuring is that regardless of whether they had multiple comorbidities or not, multiple comedications or not, the outcomes in terms of efficacy were the same and the outcomes in terms of safety, this is really important, were relatively the same. So we didn’t really see any negative impact on using these drugs in patients that have polypharmacy and several comorbidities. So this is really looking at the safety and this combines with what we presented at ESMO a few months ago looking at age. When even 30% of patients were over 75 and we didn’t see any negative impact, neither on efficacy or safety, even in the elderly patients. So very reassuring not to withhold treatment in patients that are comorbid and elderly since we can improve their outcomes since they have metastatic hormone sensitive incurable disease.
What is the clinical significance of these results?
So the significance of these studies, which obviously add to the efficacy results and the safety results, is that these treatments should not be withheld from patients that will suffer and eventually likely die of metastatic hormone sensitive prostate cancer. So this is to really try to be as inclusive as possible in managing these patients and not withhold treatment. So I think it’s important to have that added value to efficacious drugs.
Is there anything else you would like to add?
I guess the next phase of research will be to try to combine rationally multiple agents to try to treat patients most optimally up front so that we can hope to stop treatment at one point rather than keeping patients on treatment and castrate for the rest of their lives which is really one of my hopes before I retire.
