Final overall survival analysis of Phase III ARAMIS trial of Nubeqa for non-metastatic castration-resistant prostate cancer. Bayer HealthCare

Results from the preplanned final overall survival analysis of the Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial that investigated Nubeqa (darolutamide) from Bayer, in men with non-metastatic castration-resistant prostate cancer (nmCRPC) show a significant improvement in overall survival (OS) in patients receiving Nubeqa plus androgen deprivation therapy (ADT) compared to placebo plus ADT. Results of ARAMIS previously published show a statistically significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS) of darolutamide plus ADT compared to placebo plus ADT; however OS data were not yet mature at the time of the MFS analysis. 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 scientific meeting. Nubeqa an oral androgen receptor inhibitor (ARi), has been approved in the U.S., Brazil, and Japan, and filings in the European Union and other regions are underway or planned. The compound is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. Comment: On the known marker of delaying time to distant metastasis or death, or metastasis-free survival (MFS), analysts were previously split on Nubeqa’s profile. In the SPARTAN trial, Erleada showed it could cut risks by 72%, and in the PROSPER study, Xtandi demonstrated it could do so by 71%. But for Nubeqa, analysts pointed to a hazard ratio of 0.41, which means it only reduced the risk of metastasis or death by 59%—lower than the figures posted by both Xtandi and Erleada.