It has been announced that the Phase III ARAMIS Trial (Androgen Receptor inhibiting Agent for Metastatic-free Survival) evaluating an investigational treatment known as darolutamide in men with Non-metastatic Castration-resistant Prostate Cancer (nM0) has successfully met its primary endpoint of extending the metastasis-free survival (MFS) of men compared to placebo.

The ARAMIS trial was a randomized, multi-center, double-blind, placebo controlled trial in men with non-metastatic castrate resistant prostate cancer (nmCRPC). Darolutamide is an investigational, oral androgen receptor (AR) antagonist developed jointly by Bayer and Orion Corporation.

Darolutamide’s mode of action is to block the androgen receptor preventing the androgens like testosterone to act on and support the cancer’s progression.

The data from this trial still needs to be submitted to the FDA in the United States as well as the other similar regulating agencies in the rest of the world before it can come to market. It is Cancer ABCs understanding that the submission process will be quickly started.

If darolutamide (a generic name) is approved, it will be given a trade name.

Darolutamide, if approved will be filling the same niche currently filled by Erleada and Xtandi, for men who are castrate resistant (no longer having their PSA responding to first-line hormone therapy aka ADT) and who have negative scans. At the time of its approval, it will also receive a formal trade name, darolutamide is a generic name.

A Phase 3 study (ARASENS) of darolutamide in men with metastatic hormone-sensitive prostate cancer is ongoing.

Joel T Nowak, MA, MSW