- Phase III study ARANOTE to be initiated in metastatic hormone-sensitive prostate cancer (mHSPC) assessing the novel androgen-receptor antagonist in combination with standard androgen deprivation therapy
- Start of patient enrollment expected by the end of Q1 2021
- Study adds to the robust development program for darolutamide, exploring an opportunity to help even more patients with prostate cancer
Orion Corporation and Bayer are expanding the global clinical development program for the oral androgen receptor inhibitor (ARi) darolutamide in the area of prostate cancer. A new Phase III study ARANOTE will evaluate the compound in addition to androgen deprivation therapy (ADT) versus placebo plus ADT in men with metastatic hormone-sensitive prostate cancer (mHSPC). The study adds to the robust development program for the compound, including the Phase III study ARASENS, which investigates darolutamide in a triple combination with ADT and docetaxel compared to doxetacel and ADT alone in men with mHSPC.
“Darolutamide is currently approved for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. Now, it is naturally important that we also evaluate the potential of darolutamide in other stages of the disease to offer men with metastatic hormone-sensitive prostate cancer (mHSPC) a new treatment option”, said Professor, M.D., Ph.D. Outi Vaarala, Senior Vice President of Research and Development at Orion.
Darolutamide is approved in several markets around the world, including the U.S., the European Union (EU), Brazil, Canada and Japan, 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.
About the ARANOTE trial
The ARANOTE trial is a randomised, double-blind, placebo-controlled Phase III study of darolutamide in addition to androgen deprivation therapy (ADT) versus placebo plus ADT in men with metastatic hormone-sensitive prostate cancer (mHSPC). The primary endpoint of this study is radiological progression-free survival (rPFS), as measured as the time from the date of randomisation to the date of first documentation of radiological progressive disease or death due to any cause, whichever occurs first. The trial is expected to enroll about 555 men. Orion and Bayer anticipate that first patients will be enrolled to the study by end of Q1 2021.
About Metastatic Hormone-Sensitive Prostate Cancer
Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2018, an estimated 1.2 million men were diagnosed with prostate cancer, and about 358,000 died from the disease worldwide.1
At the time of diagnosis, most men have localized 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 metastasize or spread, androgen deprivation therapy (ADT) is the cornerstone of treatment for this hormone-sensitive disease. Approximately five percent 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, ARi plus ADT or a combination of the chemotherapy docetaxel and ADT. Despite this first line treatment, most men with metastatic HSPC will eventually progress to castration-resistant prostate cancer (CRPC), which can impact survival and quality of life.
Darolutamide is approved 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.
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 these trials can be found at www.clinicaltrials.gov.
Outi Vaarala, Senior Vice President, Research and Development, Orion Corporation
Tel. +358 10 426 3472
Contact person for media:
Terhi Ormio, Vice President, Communications, Orion Corporation
Tel. +358 50 966 4646
1 GLOBOCAN 2018: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2018. CA: A Cancer Journal for Clinicians. https://onlinelibrary.wiley.com/doi/epdf/10.3322/caac.21492.
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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 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.