Dr. Tagawa Discusses Darolutamide in CRPC

Scott T. Tagawa, MD
Published: Wednesday, Mar 27, 2019



Scott T. Tagawa, MD, Richard A. Stratton Associate Professor in Hematology and Oncology, associate professor of clinical medicine and urology at Weill Cornell Medicine, associate attending physician, NewYork-Presbyterian-Weill Cornell Medical Center, discusses the use of darolutamide in castration-resistant prostate cancer (CRPC).

At the 2019 Genitourinary Cancers Symposium, the presentation of the phase III ARAMIS trial garnered a lot of attention. In this study, investigators compared the use of darolutamide, a new androgen receptor inhibitor, with placebo in patients with nonmetastatic CRPC. This is a complex patient population, Tagawa says, as these patients probably do have metastatic disease, it just isn’t detectable with less sensitive imaging. With that being said, the results seen with darolutamide were expected based on data from earlier studies.

The big question is where this drug will fit in with the agents like apalutamide (Erleada) and enzalutamide (Xtandi), which have already received FDA approval. Tagawa says all 3 drugs are effective in delaying time to metastases, with a trend towards an overall survival benefit. At a quick glance, CNS toxicity appears to be better with darolutamide, although Tagawa stresses that it is difficult to make cross-study comparisons. He concludes that although he isn’t sure if this drug will receive an approval, it would be useful to the community to have another option available.
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Scott T. Tagawa, MD, Richard A. Stratton Associate Professor in Hematology and Oncology, associate professor of clinical medicine and urology at Weill Cornell Medicine, associate attending physician, NewYork-Presbyterian-Weill Cornell Medical Center, discusses the use of darolutamide in castration-resistant prostate cancer (CRPC).

At the 2019 Genitourinary Cancers Symposium, the presentation of the phase III ARAMIS trial garnered a lot of attention. In this study, investigators compared the use of darolutamide, a new androgen receptor inhibitor, with placebo in patients with nonmetastatic CRPC. This is a complex patient population, Tagawa says, as these patients probably do have metastatic disease, it just isn’t detectable with less sensitive imaging. With that being said, the results seen with darolutamide were expected based on data from earlier studies.

The big question is where this drug will fit in with the agents like apalutamide (Erleada) and enzalutamide (Xtandi), which have already received FDA approval. Tagawa says all 3 drugs are effective in delaying time to metastases, with a trend towards an overall survival benefit. At a quick glance, CNS toxicity appears to be better with darolutamide, although Tagawa stresses that it is difficult to make cross-study comparisons. He concludes that although he isn’t sure if this drug will receive an approval, it would be useful to the community to have another option available.



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