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Bayer expands global clinical program for darolutamide in prostate cancer

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Phase III study ARASTEP initiated in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline / Fifth major clinical trial for androgen receptor inhibitor (ARi) darolutamide, covering prostate cancer from early to metastatic stage 

Berlin, March 23, 2023 – Bayer further expands the global clinical development program for the oral androgen receptor inhibitor (ARi) darolutamide in prostate cancer. The new Phase III clinical study, ARASTEP, will investigate the efficacy of darolutamide plus androgen deprivation therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline. BCR is defined as rising prostate-specific antigen (PSA) levels with a doubling time of <12 months after primary treatment (surgery or radiotherapy).1,2 Darolutamide is already approved under the brand name NubeqaTM for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease as well as metastatic hormone-sensitive prostate cancer (mHSPC). Bayer estimates that the peak sales potential for Nubeqa will exceed €3 billion.

“Many patients with rising PSA levels following surgery or radiation are at an increased risk of developing metastasis. With ARASTEP, we are optimistic about the potential to help patients at this earlier stage of the disease,” said Tara Frenkl, M.D., Senior Vice President and Head of Oncology Development at Bayer. “Darolutamide has already demonstrated efficacy and safety in nmCRPC with the Phase III ARAMIS trial, and in mHSPC with the Phase III ARASENS trial. Our goal is to ensure that as many patients as possible benefit from this therapy, therefore we continue to assess the potential of darolutamide in earlier disease stages.”

The study is part of a robust global clinical development program for darolutamide. The compound is also being investigated in further studies across various stages of prostate cancer, including in the ARANOTE Phase III trial evaluating darolutamide plus androgen deprivation therapy (ADT) versus ADT alone for metastatic hormone-sensitive prostate cancer (mHSPC), as well as the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) led international Phase III co-operative group DASL-HiCaP (ANZUP1801) trial evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence.

Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

About the ARASTEP Trial
The ARASTEP trial is a randomized, double-blind, placebo-controlled Phase III study of darolutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline. The primary endpoint of this study is radiological progression-free survival (rPFS), measured by PSMA PET/CT assessed by independent central review. The trial is expected to enroll approximately 750 participants. Patients will be randomized to receive the standard regimen of 600 mg of darolutamide twice a day or matching placebo plus ADT.

About hormone-sensitive prostate cancer and biochemical recurrence (BCR)
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.3

Hormone-sensitive prostate cancer is a type of prostate cancer that needs androgens (male hormones) to grow and therefore stops growing when androgens are not present. Almost all early-stage prostate cancers are androgen-dependent.4

Up to 50% of patients with prostate cancer develop elevated prostate-specific antigen (PSA) levels in their blood after primary therapy (surgery and/or radiation therapy).5 This disease state is called biochemical recurrence (BCR). Current treatment options for patients with biochemical recurrent prostate cancer include prostatectomy, intending to be curative. If these treatments are unsuccessful, androgen deprivation therapy (ADT) is an option to control disease.2

About darolutamide (NubeqaTM)
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. This is supported by the overall low incidence of central nervous system (CNS)-related adverse events (AEs) compared to placebo as seen in the ARAMIS Phase III trial6 and the improved verbal learning and memory observed in the darolutamide arm of the Phase II ODENZA trial.7

The product is approved under the brand name Nubeqa™ in more than 80 countries around the world for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). It is also approved for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) in a number of markets including the U.S., Japan, China and the EU. Filings in other regions are underway or planned.

About Prostate Cancer at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer. Prostate cancer is the second most commonly diagnosed cancer in men3 and a key area of focus for Bayer. The company’s franchise includes two products on the market (Nubeqa™ and Xofigo™) and several compounds in development, including a unique approach of advancing targeted alpha therapies. Bayer is focused on addressing the unique needs of prostate cancer patients, providing treatments that extend their lives throughout the different stages of the disease and allowing them to continue their everyday activities, so that they can live longer, better lives.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com.

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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.


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-sensitive 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 recurrence 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 prospective, randomized, open-label, multicenter, cross-over phase II trial of preference between darolutamide and enzalutamide in men with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (CRPC). J Clin Onc 2021; 39 (15_suppl): 5046-5046.



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