Orion and Bayer broaden medical advancement program for darolutamide in prostate cancer

ORION CORPORATION
NEWS RELEASE
23 March 2023 at 15:00 EET              
        
Orion and Bayer broaden medical advancement program for darolutamide in prostate cancer

• Phase III research study ARASTEP started in hormone-sensitive prostate cancer, in clients with high-risk biochemical reoccurrence (BCR) who have no proof of metastatic illness by traditional imaging and a favorable PSMA PET/CT at standard

  

• Fifth significant medical trial for androgen receptor inhibitor (ARi) darolutamide, covering prostate cancer from early to metastatic phase

Orion and Bayer even more broaden the worldwide medical advancement program for the oral androgen receptor inhibitor (ARi) darolutamide in prostate cancer. The brand-new Phase III medical research study, ARASTEP, will examine the effectiveness of darolutamide plus androgen deprivation treatment (ADT) versus ADT alone in hormone-sensitive prostate cancer, in clients with high-risk biochemical reoccurrence (BCR) who have no proof of metastatic illness by traditional imaging and a favorable PSMA PET/CT at standard. BCR is specified as increasing prostate-specific antigen (PSA) levels with a doubling time of <12 months¹ after main treatment (surgical treatment or radiotherapy)². Darolutamide is already authorized under the trademark name Nubeqa® for the treatment of clients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high danger of establishing metastatic illness in addition to metastatic hormone-sensitive prostate cancer (mHSPC).

“Darolutamide has already shown its beneficial treatment effects in two patient groups: patients with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease as well as in patients with metastatic hormone-sensitive prostate cancer in combination with chemotherapy. As a natural continuum we want to assess the potential of darolutamide in the earlier stage of disease, and further expand the patient population that can benefit from darolutamide,” said Professor, M.D., Ph.D. Outi Vaarala, Senior Vice President of Innovative Medicines and Research and Development at Orion.

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The substance is likewise being examined in more research studies throughout different phases of prostate cancer, consisting of in the ARANOTE Phase III trial examining darolutamide plus androgen deprivation treatment (ADT) versus ADT alone for metastatic hormone-sensitive prostate cancer (mHSPC), in addition to the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) led worldwide Phase III co-operative group DASL-HiCaP (ANZUP1801) trial examining darolutamide as an adjuvant treatment for localised prostate cancer with really high danger of reoccurrence.

Darolutamide is collectively established by Orion and Bayer.

About the ARASTEP trial

The ARASTEP trial is a randomized, double-blind, placebo-controlled Phase III research study of darolutamide plus androgen deprivation treatment (ADT) versus placebo plus ADT in hormone-sensitive prostate cancer, in clients with high-risk biochemical reoccurrence (BCR) who have no proof of metastatic illness by traditional imaging and a favorable PSMA PET/CT at standard. The main endpoint of this research study is radiological progression-free survival (rPFS), determined by PSMA PET/CT evaluated by independent main evaluation. The trial is anticipated to register roughly 750 individuals. Patients will be randomized to get the basic program of 600mg of darolutamide two times a day or matching placebo, plus ADT.

About hormone-sensitive prostate cancer and biochemical recurrence (BCR)

Prostate cancer is the 2nd most frequently detected malignancy in males worldwide. In 2020, an approximated 1.4 million males were detected with prostate cancer, and about 375,000 passed away from the illness worldwide.³

Hormone-delicate prostate cancer is a kind of prostate cancer that requires androgens (male hormonal agents) to grow and for that reason stops growing when androgens are not present. Almost all early-stage prostate cancers are androgen-dependent.⁴

Up to 50% of clients with prostate cancer establish raised prostate-specific antigen (PSA) levels in their blood after main treatment (surgical treatment and/or radiation treatment).⁵ This illness state is called biochemical reoccurrence (BCR). Current treatment alternatives for clients with biochemical reoccurring prostate cancer consist of prostatectomy, meaning to be alleviative. If these treatments are not successful, androgen deprivation treatment (ADT) is an alternative to manage illness.²

About darolutamide

Darolutamide is an oral androgen receptor inhibitor (ARi) with an unique chemical structure that binds to the receptor with high affinity and shows strong antagonistic activity, therefore preventing the receptor function and the development of prostate cancer cells. The low capacity for blood-brain barrier penetration for darolutamide is supported by preclinical designs and neuroimaging information in healthy human beings. This is supported by the general low occurrence of main nerve system (CNS)-associated unfavorable occasions (AEs) compared to placebo as seen in the ARAMIS Phase III trial⁶ and the kept spoken knowing and memory observed in the darolutamide arm of the Phase II ODENZA trial.⁷

The item is authorized under the trademark name Nubeqa® in more than 80 nations around the globe for the treatment of clients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high danger of establishing metastatic illness. It is likewise authorized for the treatment of clients with metastatic hormone-sensitive prostate cancer (mHSPC) in a variety of markets consisting of the U.S., Japan, EU and China. Filings in other areas are underway or prepared by Bayer.

Contact individual:
Tuukka Hirvonen, Investor Relations
Orion Corporation
tel. +358 10 426 2721
email: [email protected]

Reference

1. Simon NI, Parker C, Hope TA, Paller CJ, Best Approaches and Updates for Prostate Cancer Biochemical Recurrence. Am Soc Clin Oncol Educ Book. 2022 Apr;42: 1–8.

2. Fakhrejahani, F., Madan, R.A. & Dahut, W.L. Management Options for Biochemically Recurrent Prostate Cancer. Curr. Treat. Options in Oncol. 2017;18 (26).

3. 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 March 2023.

4. National Cancer Institute. NCI Dictionary of Cancer Terms. Hormone-delicate prostate cancer. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/hormone-sensitive-prostate-cancer. Accessed March 2023.

5. Lin X, Kapoor A, Gu Y, Chow MJ, Xu H, Major P, et al. Assessment of biochemical reoccurrence of prostate cancer (Review). Int J Oncol. 2019 Dec;55(6):1194-212.

6. Fizazi, K et al. Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med. 2019; 380:1235–1246.

7. Colomba E. et al. ODENZA: A French potential, randomized, open-label, multicenter, cross-over stage II trial of choice in between darolutamide and enzalutamide in males with asymptomatic or slightly symptomatic metastatic castrate-resistant prostate cancer (CRPC). J Clin Onc 2021; 39 (15_suppl): 5046-5046.

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

Orion is a worldwide operating Finnish pharmaceutical business – a home builder of wellness. We establish, make and market human and veterinary pharmaceuticals and active pharmaceutical components. Orion has a substantial portfolio of proprietary and generic medications and self-care items. The core treatment locations of our pharmaceutical R&D are oncology and discomfort. Proprietary items established by Orion are utilized to treat cancer, neurological illness and breathing illness, to name a few. Orion’s net sales in 2022 totaled up to EUR 1,341 million and the business had about 3,500 staff members at the end of the year. Orion’s A and B shares are noted on Nasdaq Helsinki.