2019 American Society of Clinical Oncology (ASCO) Annual Meeting - Darolutamide data presented - Seite 3

A new post-hoc analysis of the ARAMIS data shows that treatment with darolutamide plus ADT delays the onset of urinary and bowel symptoms in men with nmCRPC compared to placebo plus ADT (urinary symptoms: 25.8 versus 4.8 months; HR=0.64; 95% CI 0.54-0.76; P<0.01; bowel symptoms: 18.4 versus 11.5 months; HR=0.78; 95% CI 0.66-0.92; P<0.01), as shown by time to deterioration of symptoms in the European Organisation for Research and Treatment of Cancer QoL Prostate Cancer module (EORTC-QLQ-PR25).¹ Statistical significance cannot be reported as these are exploratory endpoint data.¹

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 ADTand included fatigue/asthenic conditions (11.3% versus 11.1%), hypertension (4.7% versus 5.1%), falls (3.0% versus 4.6%), cognitive disorder (0.3% versus 0.2%), and memory impairment (0.4% versus 1.2%) .¹

About the ARAMIS trial
The ARAMIS trial is a randomized, Phase III, multi-center, double-blind, placebo-controlled trial evaluating the safety and efficacy of oral darolutamide in patients with nmCRPC who are currently being treated with androgen deprivation therapy (ADT) as standard of care and are at high risk for developing metastatic disease. 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of darolutamide twice a day or placebo along with ADT.

About darolutamide
Darolutamide is a non-steroidal androgen receptor (AR) antagonist with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. In preclinical studies, darolutamide demonstrated lower blood-brain barrier penetration compared to other currently available AR antagonists.⁴ 

In addition to the Phase III ARAMIS trial in men with nmCRPC, darolutamide is also being investigated in a Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS). Information about these trials can be found at www.clinicaltrials.gov.

Darolutamide is not approved by the U.S. FDA, the European Medicines Agency or any other health authority.

About castration-resistant prostate cancer (CRPC)
Prostate cancer is the second most commonly diagnosed malignancy in men worldwide.⁵ In 2018, an estimated 1.2 million men were diagnosed with prostate cancer, and about 358,000 died from the disease worldwide.⁵ Prostate cancer is the fifth leading cause of death from cancer in men.⁵ Prostate cancer results from the abnormal proliferation of cells within the prostate gland, which is part of a man's reproductive system.⁶ It mainly affects men over the age of 50, and the risk increases with age.⁷ Treatment options range from surgery to radiation treatment to therapy using hormone-receptor antagonists, i.e., substances that stop the formation of testosterone or prevent its effect at the target location.⁸ However, in nearly all cases, the cancer eventually becomes resistant to conventional hormone therapy.⁹