So the PROTEUS trial had two primary endpoints, and a series of secondary endpoints, and a couple very important exploratory endpoints. So the two primary endpoints for PROTEUS were the pathologic response of the tumor at the time of prostatectomy, that’s an early endpoint, and an endpoint called metastasis-free survival, which is a measure of the patients who develop metastasis or die...
So the PROTEUS trial had two primary endpoints, and a series of secondary endpoints, and a couple very important exploratory endpoints. So the two primary endpoints for PROTEUS were the pathologic response of the tumor at the time of prostatectomy, that’s an early endpoint, and an endpoint called metastasis-free survival, which is a measure of the patients who develop metastasis or die. In this event, metastasis-free survival was compared in the two groups. The two groups were apalutamide and ADT or placebo and ADT. So those were the two primary endpoints, major pathologic response and MFS. The secondary endpoints included event-free survival, time to the next therapy, two important ones, and then some exploratory endpoints of note are another way to measure the pathology response, which is called residual cancer burden. That takes into account the tumor cellularity as well as the size. And also a way to measure MFS, which instead of having it measured by the blinded reviewers, the central reviewers, the investigators who are treating the patient’s code, the metastasis, and that’s called investigator MFS. So those were the most important endpoints of Proteus. We’re thrilled with the results. The two co-primary endpoints were positive. There was a tenfold increase in the major pathologic response in the apalutamide cohort compared to the placebo cohort. And in addition, there was a 20% reduction in metastasis-free survival for the apalutamide and androgen deprivation therapy cohort. So two primary endpoints are positive, but in addition, some very important secondary endpoints, one called event-free survival, that’s any recurrence, was very positive for apalutamide. And strikingly, the time to the next therapy was a three-year difference almost. It was 33 months for the apalutamide and ADT compared to the placebo and ADT. So we’re very thrilled with those endpoints, and they support this type of treatment, apalutamide and androgen deprivation therapy, six months before prostatectomy, six months after as a new standard treatment option for men with localized high-risk prostate cancer.
This transcript is AI-generated. While we strive for accuracy, please verify this copy with the video.
