So in the ARCHES trial, patients were permitted to have been on antigen deprivation therapy before study entry for three months. They were also permitted to have received docetaxel chemotherapy.
This particular analysis was focused on the PSAs at the time that the patient started enzalutamide or the placebo for the ARCHES study.
So three different groups. Those patients with a PSA of less than 0...
So in the ARCHES trial, patients were permitted to have been on antigen deprivation therapy before study entry for three months. They were also permitted to have received docetaxel chemotherapy.
This particular analysis was focused on the PSAs at the time that the patient started enzalutamide or the placebo for the ARCHES study.
So three different groups. Those patients with a PSA of less than 0.4, those patients with a PSA of 0.4 to 4.0, and then patients with a PSA greater than 4.0.
It was demonstrated from the study that the hazard ratios were maintained for survival across those different subgroups in favor of enzalutamide. So this concept that you can wait to start somebody after the PSA decline declares itself. In other words, if a patient does not really decline their PSA back down to less than 0.4 or even less than 0.1, really doesn’t make sense because the benefit for enzalutamide is preserved across all of those different PSA groups.
The next steps, of course, are combinations with chemotherapy. There are trials such as ARASENS, PEACE-1 that looked at those questions. We still haven’t really answered the question as to whether you need both at this particular point, although it seems that both do seem to help these patients.
I think the next steps are to look at different combinations and also identify subgroups that may benefit more from one different treatment rather than the other.