OS improved in prostate cancer patients by Nubeqa plus androgen deprivation therapy

31 January 2020

Results from the pre-planned final overall survival analysis of the Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial that investigated Nubeqa (darolutamide) 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.

Nubeqa is an oral androgen receptor inhibitor (ARi) under development by German pharma major Bayer (BAYN: DE) and originator Finland-based Orion Corp (Nasdaq: OMX).

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.

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