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GU Cancers 2019 | ARAMIS: efficacy and safety of darolutamide in nmCRPC

Karim Fizazi, MD, PhD, of the University of Paris-Sud, Orsay, France, discusses the efficacy and safety of darolutamide in nonmetastatic castration resistant prostate cancer from the ARAMIS study (NCT02200614) which he presented at the 2019 Genitourinary Cancers Symposium, held in San Francisco, CA.

Transcript (edited for clarity)

So I also presented ARAMIS, a Phase III Trial in men with CRPC M0 here at ASCO GU here in San Francisco. And it is testing darolutamide, which is basically an AR inhibitor which is structurally distinct compared to

So I also presented ARAMIS, a Phase III Trial in men with CRPC M0 here at ASCO GU here in San Francisco. And it is testing darolutamide, which is basically an AR inhibitor which is structurally distinct compared to enzalutamide or apalutamide, the two other drugs that were tested. And it actually makes a difference because darolutamide doesn’t penetrate the blood-brain barrier and it has a very low potential for drug interaction.

So what we saw in the trial is that the primary endpoint of metastasis for survival was significantly improved. So we’re very happy about that. Again, it came together with other good news regarding efficacy. For example, overall survival over risk of death was reduced by 29%, pain progression was reduced in risk by about 35%.

The very good thing also of darolutamide, and we were really expecting that, is that the safety is just phenomenal. We actually don’t see an excess in CNS-related toxicity such as communicative impairments, fatigue, seizures or these things. No excess in fractures or falls. No excess in cardiovascular problems. It is fully good for such a population of asymptomatic men.

So we hope that this drug will come to the market for vast population of men. We will also have another program in other settings of the disease and hopefully we’ll see other good news from these Phase III programs, so that hopefully many more men will benefit because it’s active and very well tolerated.

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