This post is in Advance of Full Data Being Released by Bayer.
Results from the final overall survival analysis of the Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial that investigated Nubeqa® (aka darolutamide) in men with non-metastatic castration-resistant prostate cancer (nmCRPC) show a significant improvement in their overall survival (OS) (they lived longer) in men receiving Nubeqa plus androgen deprivation therapy (ADT) compared to men receiving a placebo plus the standard of care, ADT.
Results of ARAMIS that was previously published showed a statistically significant improvement in men’s ability to delay the development of metastasis, or of metastasis-free survival (MFS) when they took darolutamide plus ADT compared to placebo plus ADT. When these results were published the overall survival (OS) (how long a man lived) data were not yet mature and could not be evaluated.
Detailed data on the updated OS and other additional endpoints, as well as an update on longer-term safety, will be presented at an upcoming ASCO Conference.
NUBEQA is an oral (taken by mouth) androgen receptor inhibitor (ARi) that is approved in the U.S., Brazil, and Japan. According to the company, Bayer, additional filings in the European Union and other regions are underway or planned. The compound was developed jointly by both Bayer and Orion Corporation.
