2019 American Society of Clinical Oncology (ASCO) Annual Meeting - Darolutamide data presented

Orion Corporation                  Press release                         31 May 2019 at 5.00 p.m.  EEST

2019 American Society of Clinical Oncology (ASCO) Annual Meeting - Darolutamide data presented

Orion's and Bayer's darolutamide plus androgen deprivation therapy (ADT) delays worsening of disease-related symptoms and maintains quality of life beyond end of study treatment compared to placebo plus ADT in men with non-metastatic castration-resistant prostate cancer.

• Results of a new post-hoc analysis showed that treatment with darolutamide plus androgen deprivation therapy (ADT) delayed worsening of urinary and bowel symptoms versus placebo plus ADT¹
  
  
• Exposure adjusted incidences of treatment-emergent adverse events (TEAEs), including notably TEAEs associated with androgen receptor (AR) antagonists, were similar for darolutamide plus ADT compared to placebo plus ADT¹
  
  
• Darolutamide plus ADT maintained quality of life in men with non-metastatic castration-resistant prostate cancer (nmCRPC) beyond end of study treatment with scores similar to placebo plus ADT¹
  
  
• Analysis on quality of life related endpoints from pivotal Phase III ARAMIS trial presented at the American Society of Clinical Oncology (ASCO) as an oral presentation on May 31, 2019
  
  
• Darolutamide is under Priority Review in the U.S., and has been filed in Europe, Japan and additional countries

Abstract 5000
Darolutamide plus androgen deprivation therapy (ADT) delays worsening of disease-related symptoms in men with non-metastatic castration-resistant prostate cancer (nmCRPC) compared with placebo plus ADT, according to exploratory data from the pivotal Phase III ARAMIS trial presented in an oral presentation at the American Society of Clinical Oncology (ASCO) Annual
Meeting in Chicago. Exposure-adjusted incidences of treatment-emergent adverse events (TEAEs), including notably TEAEs associated with androgen receptor (AR) antagonists, were generally similar for darolutamide plus ADT compared to placebo plus ADT¹. Data also indicate that darolutamide plus ADT maintained quality of life, compared to placebo plus ADT even beyond the end of study treatment. Primary results of this study have been previously published in the New England Journal of Medicine.³ Based on the study results, the U.S. Food and Drug Administration (FDA) granted Priority Review for the New Drug Application (NDA) for darolutamide in April 2019, and Bayer has filed for approval in the European Union (EU), Japan, as well as other health authorities. Darolutamide is being developed jointly by Orion Corporation and Bayer.