Reading, UK, 17th July 2024 – The Phase III ARANOTE trial, investigating darolutamide plus ADT in patients with hormone-sensitive prostate cancer (mHSPC), has met its primary endpoint of rPFS. Darolutamide plus ADT significantly increased rPFS compared to placebo plus ADT. The safety data were comparable between both treatment arms and confirm the established tolerability profile of darolutamide in advanced prostate cancer. Darolutamide is already approved 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, and patients with mHSPC (in combination with ADT and docetaxel chemotherapy).
“We are excited to share the positive results from this Phase III trial. Following potential regulatory approval, physicians can tailor treatment plans based on individual patient´s needs,” said Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division. “Today’s results build on the established efficacy and tolerability profile for Nubeqa. We are looking forward to future outcomes of our clinical development programme investigating the compound across multiple prostate cancer stages and indications.”
Detailed results of the ARANOTE trial are planned to be presented at a forthcoming scientific congress. Bayer plans to submit the data from the study to relevant health authorities globally to support expanded use of darolutamide in men with mHSPC. ARANOTE is part of a robust clinical development programme investigating darolutamide across various stages of prostate cancer.
ENDS
Bayer Media Contact:
Veronica Yao, +44 (0) 7870 485 926
Email: veronica.yao@bayer.com
Notes to Editors
About the ARANOTE Trial
The ARANOTE trial is a randomised, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of darolutamide plus ADT in patients with mHSPC. 662 patients were randomised to receive 600mg of darolutamide twice daily or matching placebo in addition to ADT.
The primary endpoint of this study is rPFS, measured as time from randomisation to date of first documented radiological progressive disease or death due to any cause, whichever occurs first. Secondary endpoints include overall survival (time to death from any cause), time to first castration-resistant event, time to initiation of subsequent anti-cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments.
About Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
There are over 52,000 cases of prostate cancer in the UK each year,1 with over 15,000 new cases of metastatic prostate cancer confirmed each year.2
Metastatic hormone-sensitive prostate cancer (mHSPC) is cancer that has spread beyond the prostate to other parts of the body and still responds to treatment with hormone therapy.3 mHSPC precedes the development of metastatic castration-resistant prostate cancer (mCRPC),4 which no longer responds to treatment with hormone therapy.
Despite treatment, most men with mHSPC will eventually progress to mCRPC,5 a condition with limited survival.
About darolutamide (Nubeqa®)
Darolutamide is an oral ARi (androgen receptor inhibitor) 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.6
Darolutamide was authorised in March 2020 in the European Union 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.7 It was authorised in November 2022 in the UK for the treatment of patients with mHSPC in combination with docetaxel.6
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 men8 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. Bayer is focused on addressing the unique needs of patients with prostate cancer, providing treatments that extend their lives throughout the different stages of the disease and allowing them to continue with their everyday activities, so that patients 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. In line with its mission, “Health for all, Hunger for none,” the company’s 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 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to http://www.bayer.co.uk.
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.co.uk. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
References
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1 Cancer Research UK. Prostate cancer statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/prostate-cancer. Last accessed: July 2024.
2 Prostate Cancer UK. Advanced prostate cancer: your questions answered about the disease affecting Bill Turnbull. Available at: https://prostatecanceruk.org/about-us/news-and-views/2018/10/advanced-disease-blog. Last accessed: July 2024.
3 Cancer.Net. ASCO answers: Prostate Cancer. Available at: https://www.cancer.net/sites/cancer.net/files/asco_answers_guide_prostate.pdf. Last accessed: July 2024.
4Cattrini, et al. Current Treatment Options for Metastatic Hormone-Sensitive Prostate Cancer. Cancers.2019 11(9), p.1355.
5 Ritch, C. and Cookson, M. Recent trends in the management of advanced prostate cancer. F1000Res. 2018 Sep 21;7:F1000 Faculty Rev-1513.
6 NUBEQA® (darolutamide) 300 mg film-coated tables Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/11324. Last accessed: July 2024.
7 Nubeqa (darolutamide). European Medicines Agency. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/nubeqa#authorisation-details-section. Last accessed: July 2024.
8 Sung H et al. Ca Cancer J Clin 2021; 71:209–249.
RP-NUB-GB-0687 / July 2024