Orion's and Bayer's darolutamide shows substantial efficacy and a favourable safety profile in the treatment of prostate cancer in the ARAMIS trial

Orion Corporation                                                                            Press Release
Communications                                                                              14 February 2019 at 11.45 p.m. EET

Orion's and Bayer's darolutamide shows substantial efficacy and a favourable safety profile in the treatment of prostate cancer in the ARAMIS trial

American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) 2019:

Orion's and Bayer's darolutamide plus androgen deprivation therapy (ADT) significantly extends metastasis-free survival with a favorable safety profile compared to placebo plus ADT in non-metastatic castration-resistant prostate cancer.

• Statistically significant improvement in metastasis-free survival (MFS), with a median MFS of 40.4 months with darolutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT (18.4 months).
   
• Positive trend in overall survival with a 29% reduction in risk of death at interim analysis (P=0.045).
   
• Incidence of treatment-emergent adverse events was similar for darolutamide plus ADT and placebo plus ADT.
  
  
• Health-related quality of life was maintained. 
  

• First results from the Phase III ARAMIS trial with the androgen receptor antagonist darolutamide were presented in an oral presentation at American Society of Clinical Oncology Genitourinary Cancers Symposium and simultaneously published in The New England Journal of Medicine.

Abstract: 140 - ARAMIS