First presentation of data from the pivotal Phase III ARAMIS trial with the investigational compound darolutamide in patients with advanced prostate cancer that has not yet metastasized will be presented at 2019 ASCO GU Cancers Symposium.
Orion Corporation and Bayer announced today that research on their jointly developed investigational compound darolutamide will be presented at the 2019 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium taking place February 14-16 in San Francisco. Among the data presented will be the first results on the investigational cancer treatment darolutamide from the pivotal Phase III ARAMIS trial, a randomized, double-blind, placebo-controlled study to assess the safety and efficacy of darolutamide in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) being treated with androgen deprivation therapy (ADT) and at high risk for developing metastatic disease. Darolutamide is being developed jointly by Orion Corporation and Bayer.Bayer plans to discuss data from the ARAMIS trial with health authorities regarding the submission of a new drug application. Darolutamide has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in patients with nmCRPC.
Notable darolutamide studies to be presented at the 2019 ASCO GU Cancers Symposium include: ARAMIS: Efficacy and safety of darolutamide in non-metastatic castration-resistant prostate cancer (nmCRPC)
- Abstract: 140, Board A4, Poster Session A: Prostate Cancer and Trials in Progress, Oral Abstract Session A: Prostate Cancer
- Date: Thursday, February 14: 11:30 AM-1:00 PM PST and 5:30-6:30 PM PST (poster presentation), 1:45-1:55 PM PST (oral presentation)
Higher blood-brain barrier penetration of [14C]apalutamide and [14C]enzalutamide compared to [14C]darolutamide in rats using whole-body autoradiography
- Abstract: 156, Board F21, Poster Session A: Prostate Cancer and Trials in Progress
- Date: Thursday, February 14: 11:30 AM-1:00 PM PST and 5:30-6:30 PM PST
ODENZA: A study of patient preference between ODM-201 (darolutamide) and enzalutamide in men with metastatic castrate-resistant prostate cancer (mCRPC)
- Abstract: TPS334, Board N10, Poster Session A: Prostate Cancer and Trials in Progress
- Date: Thursday, February 14: 11:30 AM-1:00 PM PST and 5:30-6:30 PM PST
Drug-drug interaction (DDI) of darolutamide with cytochrome P450 (CYP) and P-glycoprotein (P-gp) substrates: Results from clinical and in vitro studies
- Abstract: 297, Board D5, Poster Session B: Prostate Cancer, Urothelial Carcinoma, and Penile, Urethral, Testicular, and Adrenal Cancers
- Date: Friday, February 15: 12:15-1:45 PM PST and 5:15-6:15 PM PST
About Darolutamide Darolutamide is a non-steroidal androgen receptor 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. Darolutamide has shown promising activity in Phase I/II studies in patients with mCRPC. A Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS) is ongoing. Darolutamide is not approved by the U.S. FDA, the European Medicines Agency or any other health authority.
