Darolutamide found favorable for patients with nmCRPC in observational DEAR study


Investigators compared 3 second-generation androgen receptor inhibitors to determine real-world utilization of the drugs and examine the incidence of adverse events.

Treatment with darolutamide (Nubeqa) was found to provide more favorable outcomes for patients with non-metastatic castration-resistant prostate cancer (nmCRPC) compared with treatment with enzalutamide (Xtandi) or apalutamide (Erleada), according to data from the DEAR study.1

Investigators showed that patients were less likely to develop metastatic disease or discontinue treatment due to adverse events when treated with darolutamide. The findings were presented at the 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California.

Daniel J. George, MD

Daniel J. George, MD

“The real-world evidence study reinforces the favorable safety profile of darolutimide in the ARAMIS study population. It further demonstrates the importance of treatment tolerability and the potential for longer treatment duration with darolutamide compared to enzalutamide and apalutamide, which may in turn improve treatment outcomes,” said Daniel J. George, MD, professor of medicine and of surgery at Duke University School of Medicine in Durham, North Carolina, during the presentation.

Investigators conducting the DEAR study compared 3 second-generation androgen receptor inhibitors, which are considered the current preferred treatment option for nmCRPC. This comparison was done to determine real-world utilization of the drugs and examine the incidence of adverse events, which are the leading cause of treatment discontinuation for androgen receptor inhibitors.

Investigators assessed electronic medical records of 828 patients with nmCRPC. Patients were divided into 3 cohorts based on treatment: darolutamide (n = 340; median age, 80 years), enzalutamide (n = 367; median age, 79 years), and apalutamide (n = 121; median age, 80 years).

Treatment discontinuation or progression to metastatic disease occurred in 37% of patients (n = 340) treated with darolutamide compared with 51% (n = 187) of patients treated with enzalutamide and 51% (n = 62) of those treated with apalutamide. The median time to discontinuation or progress to metastatic disease was not reached in the darolutamide group (95% CI, 30.1-NA). In contrast, these events occurred at a median of 23.1 months (95% CI, 18.2-26.4) in the enzalutamide group and 20.5 months (95% CI, 12.3-27.2) in the apalutamide group.

The most common reasons for treatment discontinuation included adverse events, progression to metastatic disease or death, and switching to another androgen receptor inhibitor. George noted that a lower proportion of patients in the darolutamide experienced these events compared with the other 2 groups.

In particular, adverse events occurred in 9.7% of patients in the darolutamide cohort, 14.4% in the enzalutamide cohort and 15.7% in the apalutamide cohort. Progression to metastatic disease or death was observed in 8.8% of patients treated with darolutamide, 12% in those treated with enzalutamide and 13.2% in patients treated with apalutamide.

Study authors posit the favorable outcomes in patients treated with darolutamide may be attributed to “to darolutamide being a structurally distinct (androgen receptor inhibitor) with low potential for blood–brain barrier penetration,” the researchers wrote in the abstract.


1. George DJ, Khan N, Constantinovici N, et al. Real-world use of darolutamide, enzalutamide, and apalutamide for non-metastatic castration-resistant prostate cancer (DEAR). Presented at: 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium; February 16-18, 2023; San Francisco, CA. Abstract 332.

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