New England Journal of Medicine publishes final overall survival data for darolutamide showing treatment significantly extends life in men with non-metastatic prostate cancer

• Men with non-metastatic castration-resistant prostate cancer (nmCRPC) receiving darolutamide plus androgen deprivation therapy (ADT) had a significant improvement in overall survival (OS) compared to placebo plus ADT (HR=0.69, 95% CI 0.53-0.88; p=0.003)
• Darolutamide significantly improved all other secondary endpoints, including times to first initiation of cytotoxic chemotherapy and first symptomatic skeletal event (SSE)
• The safety profile at final analysis remains consistent with the earlier analysis; overall, the rate of adverse events was comparable to ADT alone

The New England Journal of Medicine has published the full overall survival (OS) results from the pre-specified final OS analysis of the Phase III ARAMIS trial for darolutamide in men with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk for developing metastatic disease. These data were also presented as part of the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program held in May 2020.

“Through ongoing research, we have established the importance of focusing treatments on extending lives and limiting side effects for men living with nmCRPC. With these encouraging darolutamide results, physicians are further armed to treat based on the multiple needs of this patient population including efficacy, delaying morbidity and treatment tolerability,” said Karim Fizazi, M.D., Ph.D., Professor of Medicine at the Institut Gustave Roussy, Villejuif, France, and lead ARAMIS study investigator.

Men receiving darolutamide plus androgen deprivation therapy (ADT) demonstrated a significant improvement in OS compared to placebo plus ADT, with a 31 percent reduction in risk of death (HR=0.69, 95% CI 0.53-0.88; p=0.003). This OS benefit was observed despite more than half (55 percent) of patients in the placebo group (307 of 554 patients) receiving subsequent darolutamide or other life-prolonging therapy at data cut-off for final analysis (November 15, 2019).

With an extended follow-up of median 29 months for the overall study population, darolutamide continued to demonstrate a favorable safety profile. Discontinuation of treatment due to adverse events (AEs) was unchanged from the primary analysis, occurring in 9 percent of patients in both arms of the study.

This updated analysis of the ARAMIS trial also confirms the low potential for central nervous system (CNS) effects, such as mental impairment and cognitive impairment, expected with darolutamide plus ADT.

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 ADT and are at high risk for developing metastatic disease. In the clinical study, 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of darolutamide orally twice daily or placebo along with ADT. Patients with a history of seizure were allowed in the study.

Previously published results from the ARAMIS trial demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months for darolutamide plus ADT compared to 18.4 months for placebo plus ADT (p<0.001).

About darolutamide
Darolutamide is an oral androgen receptor inhibitor (ARi) 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. The compound is also being investigated in a Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS). Information about the trials can be found at www.clinicaltrials.gov.

Darolutamide was approved in March 2020 in the European Union (EU) under the brand name Nubeqa® for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. Nubeqa® has also received regulatory approval in the U.S., Australia, Brazil, Canada as well as Japan, and filings in other regions are underway or planned.

Contact persons:

Paula Rytilä, Chief Medical Officer, Orion Corporation
Tel. +358 10 426 4416
paula.rytila@orion.fi

Contact person for media:

Terhi Ormio, Vice President, Communications, Orion Corporation
Tel. +358 50 966 4646
terhi.ormio@orion.fi

Publisher:
Orion Corporation
Communications
Orionintie 1A, FI-02200 Espoo, Finland
www.orion.fi

Orion is a globally operating Finnish pharmaceutical company – a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals and active pharmaceutical ingredients. The company is continuously developing new drugs and treatment methods. The core therapy areas of Orion's pharmaceutical R&D are central nervous system (CNS) disorders, oncology, Finnish heritage rare diseases and respiratory diseases for which Orion develops inhaled Easyhaler® pulmonary drugs. Orion's net sales in 2019 amounted to EUR 1,051 million and the company had about 3,300 employees at the end of the year. Orion's A and B shares are listed on Nasdaq Helsinki.