In a subgroup analysis of the pivotal phase 3 ARAMIS trial, it was shown that the efficacy of darolutamide (Nubeqa) was sustained in men who experience a rapid PSA doubling time.

The analysis demonstrated that Darolutamide (Nubeqa) is effective in treating men who have prostate cancer who are at high-risk but are non-metastatic and castration-resistant (nmCRPC)and who have a fast PSA doubling time (PSADT) between 6 and 10 months. This subgroup analysis was presented during the 2020 European Association of Urology Virtual Congress.1

The analysis showed that among men with a PSADT ≤6 months, darolutamide reduced the risk of developing metastases or death by 59% versus placebo. This benefit with Nubeqa was similar to that observed in men with a PSADT >6 months, in whom there was a 62% reduction in the risk of metastases or death.

The safety profile for darolutamide was similar between the two populations.

“These results tell us that men who have a PSADT between 6 and 10 months can also benefit from Nubeqa without increased safety risk,” said lead study author Martin Bögemann, MD, Münster University Medical Center, Department of Urology, Münster, Germany.

Since these men who have non-metastatic CRPC with a PSADT ≤6 months are at the highest risk of metastatic progression, this is good news.

1. Bögemann MWH, Shore ND, Tammela TLJ, et al. Efficacy and safety of darolutamide (DARO) in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and a prostate-specific antigen doubling time (PSADT) >6 months. 2020 European Association of Urology Virtual Congress. July 17-26, 2020. Abstract 919.