Bayer's darolutamide meets in Phase III for non-metastatic CRPC

Bayer AG (Xetra:BAYN) said darolutamide (ODM-201, BAY1841788) met the primary endpoint of improving metastasis-free survival vs. placebo in the Phase III ARAMIS trial to treat non-metastatic castration-resistant prostate cancer (CRPC). The company did not disclose detailed data, but said it plans to discuss the results with regulatory authorities. Full data are slated to be presented at an upcoming scientific meeting. Darolutamide is a non-steroidal androgen receptor antagonist.

The double-blind, international trial enrolled 1,508 patients who were receiving androgen deprivation therapy and were at risk for developing metastatic disease to receive placebo or twice-daily 600 mg oral darolutamide...