The results of the ARAMIS phase III trial of darolutamide in patients with non-metastatic castration-resistant prostate cancer will be presented on 14 February 2019 at the Genitourinary Cancers Symposium (ASCO GU). The abstracts will be published on 11 February.
The 2019 Genitourinary Cancers Symposium (ASCO GU) will take place in San Francisco on 14-16 February.
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)
Higher blood-brain barrier penetration of [14C]apalutamide and [14C]enzalutamide compared to [14C]darolutamide in rats using whole-body autoradiography
ODENZA: A study of patient preference between ODM-201 (darolutamide) and enzalutamide in men with metastatic castrate-resistant prostate cancer (mCRPC)
Drug-drug interaction (DDI) of darolutamide with cytochrome P450 (CYP) and P-glycoprotein (P-gp) substrates: Results from clinical and in vitro studies
The ARAMIS trial
Orion and Bayer announced on 24 October 2018 that they had completed the phase III clinical trial (ARAMIS) of darolutamide, the novel oral androgen receptor antagonist for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).
The primary endpoint of the trial was met: Darolutamide significantly extended metastasis-free survival compared to placebo.The safety profile and the tolerability of darolutamide observed in the ARAMIS trial were consistent with previously published data on darolutamide.
Commenced in 2014, the ARAMIS trial evaluated the efficacy and safety of darolutamide in patients with non-metastatic castration-resistant prostate cancer who are currently being treated with androgen deprivation therapy (ADT) as standard of care and are at risk of developing metastatic disease. In the double-blind, placebo-controlled trial, more than 1,500 patients were randomized to receive 600 mg of darolutamide or matching placebo twice a day. The primary endpoint was metastasis-free survival, defined as time between randomization and evidence of metastasis or death from any cause.
Read more in Orion's R&D pipeline
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. 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.
For more information on the headline results and financial terms, see stock exchange release on 24 October 2018.
