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The Impact of Recently Approved AR-Targeted Therapy

Insights From:Alicia Morgans, MD, MPH, Northwestern University Feinberg School of Medicine; Matthew R. Smith, MD, PhD, Massachusetts General Hospital Cancer Center
Published: Monday, Jan 13, 2020



Transcript: 

Elizabeth Heath, MD:
I think there is finally an opportunity for practitioners to be able to prescribe any 1 of those 3 medications. The selection process gets a little trickier, in terms of who should get what. There are certain nuances from all 3 trials that you have to factor in. Some are sort of the question of, “Well, what do you get if you’re on the placebo, and then you cross over to an active agent? Is there some controlling of that?” So there are some differences with that. But the adverse-effect profile will drive the patient selection. That’s really up to the practitioner to gauge for each patient.

Alicia Morgans, MD, MPH: Prior to the approval of enzalutamide, apalutamide, and darolutamide for nonmetastatic CRPC [castration-resistant prostate cancer], we didn’t have an agent that could definitively prolong a real meaningful end point. Prior to the approval, we actually used bicalutamide simply to lower the PSA, but we didn’t know if that drug would actually prolong survival or metastasis-free survival. We had no data to really describe that. But now with the approval of these drugs, we know that we can prolong the time to metastasis and increase metastasis-free survival, which is both clinically meaningful and, for some of these drugs, appears to be associated with a probable overall survival benefit as well. It’s really a new era in treating patients with nonmetastatic CRPC.

The unmet needs in treating nonmetastatic CRPC, from my perspective, are that we still need a better understanding of how novel imaging is going to impact our treatment landscape. When we talk with other clinicians and patients about this, we tell them that these studies were designed around standard imaging. But as more and more clinicians are moving to novel imaging practices, it becomes complicated to say to a patient that you’re nonmetastatic when the patient can see that there are areas that are lighting up on these new scans. When we apply the data, certainly we know that those patients are nonmetastatic by standard imaging; still, the drugs will work. But I look forward to having some better clinical guidance around how to think about that imaging and how to make patients and clinicians more comfortable when trying to understand the data in the context of novel imaging.


Transcript Edited for Clarity 
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Transcript: 

Elizabeth Heath, MD:
I think there is finally an opportunity for practitioners to be able to prescribe any 1 of those 3 medications. The selection process gets a little trickier, in terms of who should get what. There are certain nuances from all 3 trials that you have to factor in. Some are sort of the question of, “Well, what do you get if you’re on the placebo, and then you cross over to an active agent? Is there some controlling of that?” So there are some differences with that. But the adverse-effect profile will drive the patient selection. That’s really up to the practitioner to gauge for each patient.

Alicia Morgans, MD, MPH: Prior to the approval of enzalutamide, apalutamide, and darolutamide for nonmetastatic CRPC [castration-resistant prostate cancer], we didn’t have an agent that could definitively prolong a real meaningful end point. Prior to the approval, we actually used bicalutamide simply to lower the PSA, but we didn’t know if that drug would actually prolong survival or metastasis-free survival. We had no data to really describe that. But now with the approval of these drugs, we know that we can prolong the time to metastasis and increase metastasis-free survival, which is both clinically meaningful and, for some of these drugs, appears to be associated with a probable overall survival benefit as well. It’s really a new era in treating patients with nonmetastatic CRPC.

The unmet needs in treating nonmetastatic CRPC, from my perspective, are that we still need a better understanding of how novel imaging is going to impact our treatment landscape. When we talk with other clinicians and patients about this, we tell them that these studies were designed around standard imaging. But as more and more clinicians are moving to novel imaging practices, it becomes complicated to say to a patient that you’re nonmetastatic when the patient can see that there are areas that are lighting up on these new scans. When we apply the data, certainly we know that those patients are nonmetastatic by standard imaging; still, the drugs will work. But I look forward to having some better clinical guidance around how to think about that imaging and how to make patients and clinicians more comfortable when trying to understand the data in the context of novel imaging.


Transcript Edited for Clarity 
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