Phase III ARAMIS trial investigating darolutamide meets primary endpoint for treatment of prostate cancer
The RCT reports a statistically significant improvement in metastasis-free survival, with a median of 40.4 months for darolutamide (an androgen receptor antagonist) vs 18.4 months for placebo plus androgen-deprivation therapy.
Source:
Biospace Inc.
SPS commentary:
The European CHMP has recommended approval of a marketing authorisation application for darolutamide for the treatment of adult men with non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.