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In the ARAMIS trial, darolutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT significantly improved metastasis-free survival (MFS), overall survival (OS) and time to pain progression in patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

This is a summary of a publication about the ARAMIS (Androgen Receptor Antagonizing Agent for Metastasis-free Survival) trial, which was published in the New England Journal of Medicine in September 2020.

Darolutamide, an oral androgen receptor inhibitor, has been approved for treating nonmetastatic castration-resistant prostate cancer (nmCRPC), based on significant improvements in metastasis-free survival (MFS) in the ARAMIS clinical trial.

Darolutamide is a structurally distinct androgen-receptor inhibitor that is approved for the treatment of nonmetastatic, castration-resistant prostate cancer. In the planned primary analysis of a phase 3 trial, the median metastasis-free survival was significantly longer with darolutamide (40.

Patients with non-metastatic castration-resistant prostate cancer (nmCRPC, formerly known as M0 CRPC) have rising prostate-specific antigen (PSA) levels despite castrate levels of testosterone with approved androgen deprivation therapy (ADT) and no detectable metastases on conventional imaging with computed tomography (CT) and bone scans.1
San Francisco, CA (UroToday.com)  -- Results from the preplanned final overall survival analysis of the Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial that investigated NUBEQA® (darolutamide) in men with non-metastatic castration-resistant prostate cancer (nmCRPC) show a significant improvement in overall survival (OS) in patients receiving NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT. Results of ARAMIS previously published show a statistically significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS) of darolutamide plus ADT compared to placebo plus ADT; however OS data were not yet mature at the time of the MFS analysis. Detailed data on the updated OS and other additional endpoints as well as an update on longer term safety will be presented at an upcoming scientific meeting.

In July 2019, darolutamide became the newest available oral androgen receptor inhibitor approved by the FDA for the treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC) patients. The Phase 3 ARAMIS trial evaluated darolutamide with androgen deprivation therapy (ADT) versus ADT plus placebo for nmCRPC patients and demonstrated significant improvement in metastasis-free survival (MFS), extending MFS to 40 months for those treated with darolutamide as opposed to 18 months for patients randomized to the ADT + placebo arm.

Published Date: September 2019

Androgen deprivation therapy (ADT) is the longstanding initial treatment for advanced hormone-sensitive prostate adenocarcinoma. Nonetheless, patients who are initiated on ADT will invariably progress by developing prostate cancer cellular clonal populations, which creates a phenotype of more castration-resistant disease with more aggressive biology.1

Chicago, IL (UroToday.com)  -- Darolutamide, an androgen receptor inhibitor, has received FDA approval for the treatment of patients with nonmetastatic castration resistant prostate cancer (CRPC)1 This priority review is based on the Phase III ARAMIS trial evaluating darolutamide plus androgen deprivation therapy (ADT), which demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS).
BACKGROUND: Darolutamide is a structurally unique androgen-receptor antagonist that is under development for the treatment of prostate cancer. We evaluated the efficacy of darolutamide for delaying metastasis and death in men with nonmetastatic, castration-resistant prostate cancer.
San Francisco, CA USA (UroToday.com) -- The Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial that investigated darolutamide in men with non-metastatic castration-resistant prostate cancer (nmCRPC), met its primary endpoint. Darolutamide significantly extended metastasis-free survival (MFS) compared to placebo. The safety profile and the tolerability of darolutamide observed in the ARAMIS trial were consistent with previously published data on darolutamide. ARAMIS is a randomized, multi-center, double-blind, placebo-controlled trial in patients with nmCRPC. Darolutamide is an investigational, oral androgen receptor (AR) antagonist developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.
Conference Coverage
Conference Highlights Written by Physician-Scientist
Presented by Karim Fizazi, MD, PhD
Darolutamide (DARO) is a structurally distinct androgen receptor inhibitor (ARI) that has been demonstrated to significantly prolong metastasis-free survival and overall survival in the ARAMIS trial.1
Presented by Susan Feyerabend
Darolutamide significantly prolonged metastasis-free survival (MFS) and overall survival (OS) vs placebo (PBO) in men with nonmetastatic castration-resistant prostate cancer (nmCRPC) in ARAMIS.
Presented by Karim Fizazi, MD, PhD
Patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) need therapy that prolongs survival with little added toxicity, thus preserving quality of life.
Presented by Neal D. Shore, MD, FAC
In plenary abstract presentation in the Poster Highlights Session: Prostate Cancer - Localized Disease session at the 2021 ASCO GU meeting, Dr. Shore and colleagues presented an analysis examining the effect of crossover on the overall survival benefit seen in ARAMIS.
Presented by Matthew R. Smith, MD, Ph.D
There has been a rapid evolution in treatment options for patients with non-metastatic castration-resistant prostate cancer (nmCRPC) since the spring of 2018. Up until the presentation of SPARTAN and PROSPER trials, reporting on the use of apalutamide and enzalutamide in nmCRPC
Presented by Karim Fizazi, MD, Ph.D.
There has been a rapid evolution in treatment options for patients with non-metastatic castration-resistant prostate cancer (nmCRPC) since the spring of 2018. Up until the presentation of SPARTAN and PROSPER trials, reporting on the use of apalutamide and enzalutamide in non-metastatic castration-resistant prostate cancer, at GU ASCO in February 2018, there were no specifically approved treatment options for these patients.
Presented by Karim Fizazi, MD, PhD
There has been a rapid evolution in treatment options for patients with non-metastatic castration-resistant prostate cancer since the spring of 2018. Up until the presentation of SPARTAN and PROSPER trials, reporting on the use of apalutamide and enzalutamide in non-metastatic castration-resistant prostate cancer, at GU ASCO in February 2018, there were no specifically approved treatment options for these patients.
Presented by Karim Fizazi, MD, Ph.D.
Darolutamide is a unique androgen receptor inhibitor, FDA approved in July 2019 for the treatment of non-metastatic castration-resistant prostate cancer. This approval was based on ARAMIS,1 a large multicenter double-blind, placebo-controlled study that randomized 1500 patients to 600 milligrams of darolutamide twice a day or placebo.
Presented by Peter Albers, MD
Barcelona, Spain (UroToday.com) In the last year, we have had three new treatment options emerge for patients with M0, non-metastatic CRPC (nmCRPC). At GU ASCO 2018, both PROSPER 1 and SPARTAN 2 presented results of their phase III trials – both presenting metastases-free survival (MFS) as the primary endpoint. 
Presented by Teuvo Tammela, MD, PhD
Barcelona, Spain (UroToday.com)  Dr. Teuvo Tammela presented results of the recently published ARAMIS trial. Non-metastatic (M0) CRPC (nmCRPC) is defined as a rising PSA in the setting of non-metastatic disease in the castrate state.
Presented by Karim Fizazi, MD, Ph.D.
San Francisco, CA (UroToday.com) The treatment landscape for non-metastatic castration-resistant prostate (nmCRPC) cancer is rapidly evolving. In 2018, Enzalutamide (July 2018) and Apalutamide (February 2018) became the first two drugs to obtain FDA approval for the treatment of nmCRPC. SPARTAN was a phase 3 double-blind, randomized study of apalutamide versus placebo in patients nmCRPC.
Presented by Ian D. Davis, MBBS, Ph.D.
San Francisco, CA (UroToday.com) Dr. Ian Davis provided a discussion of the 3 positive clinical trials just presented – LATITUDE (final results), ARAMIS, and ARCHES. He did start by noting his conflicts of interest, particularly that he is an advisor for many of the companies – but also, that as an Australian, he is a believer in affordable universal health care (and cost-effective healthcare delivery).
Presented by Karim Fizazi, MD, PhD
San Francisco, CA (UroToday.com) The use of androgen-axis targeted agents, specifically enzalutamide and abiraterone, have drastically changed the landscape of advanced prostate cancer management. Just last year, at GU ASCO 2018,