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

Nachrichtenquelle: GlobeNewswire
14.02.2019, 22:45  |  450   |   |   

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

Results from the pivotal Phase III ARAMIS trial in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) showed a statistically significant improvement in metastasis-free survival (MFS) with darolutamide plus standard of care (ADT) compared to placebo plus ADT (HR=0.41, 95% CI 0.34-0.50; P<0.001). This translates to a 59 percent reduction in the risk of metastasis or death. The median MFS was 40.4 months in the darolutamide arm compared with 18.4 months for the placebo arm - an overall improvement in median MFS of 22 months.

A positive trend in overall survival (OS) was also observed (HR=0.71, 95% CI 0.50-0.99; P=0.045), and all other secondary endpoints demonstrated a benefit in favor of darolutamide. Importantly, the incidence of treatment-emergent adverse events (AEs) with greater than or equal to 5 percent frequency or of grade 3-5 was comparable between darolutamide and placebo arms; only fatigue occurred in more than 10 percent of patients (darolutamide plus ADT resulted in 12.1 percent versus 8.7 percent in patients with placebo plus ADT). Quality of life outcomes were similar between the treatment groups.

These data were presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in San Francisco and published simultaneously in The New England Journal of Medicine.  

"In addition to a benefit in MFS, a favorable safety profile is critical for these largely asymptomatic nmCRPC patients because treatment decisions can impact their overall well-being, prognosis, compliance with the treatment as well as other medications that are typical for this patient population. These data are exciting for the prostate cancer community; they not only show darolutamide's significant efficacy in preventing the spread of prostate cancer, but also its favorable tolerability profile that, once approved, may allow patients to continue their day-to-day life without adding any burden," said Karim Fizazi, M.D., Ph.D., Professor of Medicine at the Institut Gustave Roussy, University of Paris Sud, France.

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