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STOCK EXCHANGE RELEASE / INSIDE INFORMATION
3 DECEMBER 2021 at 8.30 EET
ARASENS trial with darolutamide in combination with docetaxel and androgen deprivation therapy meets primary endpoint of significantly increasing overall survival in patients with metastatic hormone-sensitive prostate cancer
Orion’s and Bayer’s Phase III ARASENS trial demonstrates an increase in overall survival evaluating darolutamide in combination with docetaxel and androgen deprivation therapy (ADT) compared to docetaxel and ADT, a standard of care in metastatic hormone-sensitive prostate cancer (mHSPC)
Bayer plans to present these pivotal data at a forthcoming scientific congress and discuss them with health authorities
ARASENS is part of development program for darolutamide which includes another ongoing Phase III trial in mHSPC, ARANOTE, evaluating darolutamide and ADT
The Phase III ARASENS trial investigating the use of the oral androgen receptor inhibitor (ARi) darolutamide in metastatic hormone-sensitive prostate cancer (mHSPC) has met its primary endpoint. In the ARASENS trial, darolutamide in combination with docetaxel and androgen deprivation therapy (ADT) significantly increased overall survival (OS) compared to placebo, docetaxel and ADT. The overall incidence of reported adverse events was similar between treatment arms. Detailed results of the study are planned to be presented at an upcoming scientific congress. The ARASENS trial is the only Phase III randomised, multi-centre, double-blind, placebo-controlled trial which was prospectively designed to evaluate the efficacy and safety of a combination of an ARi with docetaxel and ADT compared to docetaxel and ADT in patients with mHSPC.
Darolutamide is approved in multiple markets around the world, including the U.S., the European Union (EU), Japan and China, under the brand name Nubeqa®, for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. Filings in other regions are underway or planned by Bayer. The product is developed jointly by Orion and Bayer.
“I would like to thank all the patients and investigators participating in the ARASENS study. The results show that darolutamide, a compound discovered by Orion’s scientists, in combination with docetaxel and androgen deprivation therapy improves overall survival for patients with metastatic hormone-sensitive prostate cancer. We share with our partner the excitement about this new combination approach as a potential new treatment option for men with mHSPC”, said Professor, M.D., Ph.D. Outi Vaarala, Senior Vice President of Research and Development at Orion.
Bayer plans to discuss the data from ARASENS with health authorities worldwide regarding the submission for marketing authorisation in this indication.
About the ARASENS trial
The ARASENS trial is a randomised, Phase III, multi-centre, double-blind, placebo-controlled trial which was prospectively designed to investigate the safety and efficacy of oral darolutamide, an androgen receptor inhibitor (ARi) in combination with the chemotherapy docetaxel and androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). 1,306 newly diagnosed patients were randomised in a 1:1 ratio to receive 600 mg of darolutamide twice a day or matching placebo, in addition to docetaxel and standard ADT.
The primary endpoint of this trial is overall survival (OS). Secondary endpoints include time to castration-resistant prostate cancer (CRPC), time to initiation of subsequent anticancer therapy, time to first symptomatic skeletal event (SSE), time to pain progression, all measured at 12‐week intervals, as well as adverse events as a measure of safety and tolerability.
About Metastatic Hormone-Sensitive Prostate Cancer
Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, and about 375,000 died from the disease worldwide.1
At the time of diagnosis, most men have localised prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. Upon relapse when the disease will metastasise or spread, androgen deprivation therapy (ADT) is the cornerstone of treatment for this hormone-sensitive disease. Approximately 5% of men will already suffer from prostate cancer with distant metastases when first diagnosed. Men with metastatic hormone-sensitive prostate cancer (mHSPC) will start their treatment with hormone therapy, such as ADT, androgen receptor inhibitor (ARi) plus ADT or a combination of the chemotherapy docetaxel and ADT. Despite this treatment, most men with mHSPC will eventually progress to castration-resistant prostate cancer (CRPC), a condition with limited survival.
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 low potential for blood brain barrier penetration for darolutamide is supported by preclinical models and neuroimaging data in healthy humans. A low blood-brain barrier penetration would explain the overall low incidence of central nervous system (CNS)-related adverse events (AEs) compared to placebo as seen in the ARAMIS Phase III trial and significant improvement in verbal memory in the Phase II ODENZA trial. The product is approved under the brand name Nubeqa® in several markets around the world for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. The compound is also being investigated in further studies across various stages of prostate cancer, including another Phase III trial in metastatic hormone-sensitive prostate cancer (mHSPC) (ARANOTE) as well as Phase III trial evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence (DASL-HiCaP). Information about these trials can be found at www.clinicaltrials.gov.
Tuukka Hirvonen, Investor Relations, Orion Corporation
Tel. +358 10 426 2721
Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA: A Cancer Journal for Clinicians. https://acsjournals.onlinelibrary.wiley.com/doi/epdf/10.3322/caac.21660. Accessed October 2021.
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 neurological disorders, oncology and respiratory diseases for which Orion develops inhaled pulmonary medication. Orion's net sales in 2020 amounted to EUR 1,078 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.