Neal Shore, FACS, MD, Carolina Urologic Research Center, Myrtle Beach, SC, discusses some of his highlights from ASCO GU 2021, including a number of studies presented in non-metastatic castration-resistant prostate cancer (nmCRPC). The Phase III ARAMIS trial (NCT02200614) evaluated the overall survival benefit of darolutamide, an antrogen receptor inhibitor, compared to placebo in patients with high-risk nmCRPC. Dr. Shore also describes two post hoc analyses of data obtained from the Phase III PROSPER trial (NCT02003924) of enzalutamide plus androgen deprivation therapy in patients with nmCRPC. This interview took place during the 2021 Genitourinary Cancers Symposium.
Transcript (edited for clarity)
I think there’s really a lot of interesting things going on, and presumably going forward we’ll start to have these hybrid meetings where we’ll still have virtual, but also add in, layer in, in-person connectivity. For me, this year it was great fun to be part of GU ASCO, as it always is. I had the opportunity, along with my colleagues, to present a different and what I think are really important changes to help patient care...
I think there’s really a lot of interesting things going on, and presumably going forward we’ll start to have these hybrid meetings where we’ll still have virtual, but also add in, layer in, in-person connectivity. For me, this year it was great fun to be part of GU ASCO, as it always is. I had the opportunity, along with my colleagues, to present a different and what I think are really important changes to help patient care.
So with regards to the ARAMIS trial, the Phase III nmCRPC study, we presented crossover analyses on the overall survival benefit which demonstrated the advantages of using darolutamide as opposed to a control placebo, and we did a rather in-depth sensitivity analysis using some different metrics, and it clearly continued to demonstrate the value of starting a patient on a darolutamide with the proper diagnosis of nmCRPC. Additionally, we presented further safety analysis, long-term safety analysis, and I’m really hearkened by the really good tolerability of darolutamide, and part of that has to do with it’s really very low blood-brain barrier penetration.
I think moving forward for our colleagues, we have three nmCRPC approved agents. Darolutamide, apalutamide, enzalutamide, and we’ll continue to all learn about not only the MFS benefit, the OS benefit, which all have seen, but patient tolerability and safety and drug-drug interaction.
Additionally, on top of that, I was involved with a couple of PROSPER, really important sub analyses. One was on looking at the PROSPER population regarding both age and by region and demonstrating whether it was a cut point of younger than 70 or over 70, or all different regions throughout the world. We saw benefit of enzalutamide versus the placebo ADT control. So again, very important that our colleagues recognize that another AR pathway inhibitor that’s very effective in nmCRPC.
And then a really, a pretty cool subanalysis that was presented was on PSA decline. And we really saw a predictive example with Kaplan-Meiers, whether the PSA declination was less than 0.2 or between a PSA90 of greater that never reached 0.2, and PSA50s. Really interesting analysis now to look at PSA as a surrogate of response in this nmCRPC population. And I think that was a very compelling presentation.