Neal Shore, FACS, MD, Carolina Urologic Research Center, Myrtle Beach, SC, provides an overview of some of the key studies he and his colleagues presented at ASCO GU 2021 in advanced and metastatic prostate cancer, including a sub-group analysis from the Phase III HERO study (NCT03085095), which evaluated the efficacy and safety of concomitant relugolix in advanced prostate cancer. Other studies described include a post hoc analysis of the Phase III ARCHES trial (NCT02677896), which demonstrates clinical benefit of enzalutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC). This interview took place during the 2021 Genitourinary Cancers Symposium.
Transcript (edited for clarity)
We also presented an analysis on the HERO population, the Phase III trial of relugolix. And we looked at the use of relugolix with patients who are receiving, or who had, concomitant use of either docetaxel or enzalutamide or radiation therapy versus the LHRH population, and we saw continued supportive efficacy of the testosterone suppression and no untoward safety signals and any imbalance. So I do think relugolix, this oral GnRH antagonist has been a really important 2020 advancement for our patients with ADT...
We also presented an analysis on the HERO population, the Phase III trial of relugolix. And we looked at the use of relugolix with patients who are receiving, or who had, concomitant use of either docetaxel or enzalutamide or radiation therapy versus the LHRH population, and we saw continued supportive efficacy of the testosterone suppression and no untoward safety signals and any imbalance. So I do think relugolix, this oral GnRH antagonist has been a really important 2020 advancement for our patients with ADT.
On top of that, we presented some real-world evidence of how our colleagues are sequencing radium-223 after first-line novel hormonal agents in nmCRPC. And I think one of the take-homes there, and we recognized that the more therapies that patients can receive with nmCRPC in a timely and appropriate fashion tends to not prevent other therapies such as the use of taxane based treatment, but ultimately at the end of the day provides prolongation of survival.
We had a really nice presentation and poster of the ARCHES trial, the use of enzalutamide in nmCSPC. We looked at the difference between patients who had presented with de novo metastatic versus those who had a recurrent or what some would call primary progressive. And this was a really interesting study, continuing to show the benefit of enzalutamide in either one of these populations.
Additionally, we worked on a Phase II study of an oral docetaxel with a small European based company called Modra Pharmaceuticals, but we had both US and European sites, and we saw a really, a very nice efficacy of the oral taxane therapy in combination with ritonavir, which helps the biomolecular and biophysiology of the oral taxane. We saw presented its efficacy and safety, kind of a nice option for oral therapy, especially during a pandemic.
Additionally, we presented the use of a PIK3-AKT inhibitor, capivasertib, in combination with abiraterone as a Phase I study in mCRPC patients. I think that this further use of a PIK3-AKT inhibitor based upon molecular stratification of P-10 loss, particularly with NGS as opposed to IHC, but we still need to get greater interrogation on this. How can we combine two different targeted areas to help our patients in certain populations? And we looked at the safety and that tolerability, and that was also presented.
And then finally, another really kind of a cool look back on, a retrospective analysis of a large number of patients in the US was combining the Prolaris CCP score and the CAPRA score, or what we now call the CCR, and finding that by this risk stratification could give us an opportunity compared to just looking at these constructs of CCP separately or CAPRA separately, or NCCN metrics parameters separately by the combining and looking at the CCR, we’re able to better inform patients who may not necessarily need ADT while they’re getting radiation therapy in the intermediate risk group and even the high and the very high risk groups. Really kind of a fascinating and important retrospective analysis, and that’s a publication that’s in progress.
A really fun and busy ASCO GU, and I’m excited for 2021 and hope that our colleagues continue to have opportunity to learn virtually, but also as the pandemic hopefully subsides, we’ll have an opportunity to meet each other in person again.