I was privileged to be the discussant today for three very important trials. ARAMIS, the update of the LATITUDE data, and the first presentation of the ARCHES data. ARAMIS was a very interesting study, this was looking at darolutamide versus placebo in M0 castrate-resistant prostate cancer.
So, this is an entity that is becoming vanishingly small as we have better imaging modalities. And, the implications of having this diagnosis still remain very unclear. These are patients who have recurrent PSA despite androgen deprivation therapy, but no overt evidence of metastatic disease on conventional imaging.
And the study has shown very clearly that darolutamide in this setting is superior to placebo in terms of the primary endpoint of the study, which was metastasis free survival. This is a registration input for the FDA, so this is a positive study for the company. It’s not yet clear whether this is going to translate into overall survival. We suspect that it will, but the trial is still too immature to give us that information.