September 09, 2020
Not intended for U.S. and UK Media

New England Journal of Medicine publishes final overall survival data for Nubeqa™ (darolutamide) showing treatment significantly extends life in men with non-metastatic prostate cancer

Men with non-metastatic castration-resistant prostate cancer (nmCRPC) receiving darolutamide plus androgen deprivation therapy (ADT) had a significant improvement in overall survival (OS) compared to placebo plus ADT (HR=0.69, 95% CI 0.53-0.88; p=0.003) / Darolutamide significantly improved all other secondary endpoints, including time to first initiation of cytotoxic chemotherapy and first symptomatic skeletal event (SSE) / The safety profile at final analysis remains consistent with the earlier analysis; overall, the rate of adverse events was comparable to ADT alone

Berlin, September 9, 2020 -The New England Journal of Medicine today published the full overall survival (OS) results from the pre-specified final OS analysis of the Phase III ARAMIS trial for darolutamide (Nubeqa™) in men with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk for developing metastatic disease. These data were also presented as part of the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program held in May 2020.

"Through ongoing research, we have established the importance of focusing treatments on extending lives and limiting side effects for men living with nmCRPC. With these encouraging darolutamide results, physicians are further armed to treat based on the multiple needs of this patient population including efficacy, delaying morbidity and treatment tolerability," said Karim Fizazi, M.D., Ph.D., Professor of Medicine at the Institut Gustave Roussy, Villejuif, France, and lead ARAMIS study investigator.

Men receiving darolutamide plus androgen deprivation therapy (ADT) demonstrated a significant improvement in OS compared to placebo plus ADT, with a 31 percent reduction in risk of death (HR=0.69, 95% CI 0.53-0.88; p=0.003). This OS benefit was observed despite more than half (56 percent) of patients in the placebo group (309 of 554 patients) receiving subsequent darolutamide or other life-prolonging therapy at data cut-off for final analysis (November 15, 2019).

With an extended follow-up of median 29 months for the overall study population, darolutamide continued to demonstrate a favorable safety profile. Discontinuation of treatment due to adverse events (AEs) was unchanged from the primary analysis, occurring in 9 percent of patients in both arms of the study.

This updated analysis of the ARAMIS trial also confirms the low potential for central nervous system (CNS) effects, such as mental impairment and cognitive impairment, expected with darolutamide plus ADT. This effect may be explained by the low blood-brain barrier penetration observed in preclinical and clinical studies.(1),

About the ARAMIS trial
The ARAMIS trial was a randomized, Phase III, multi-center, double-blind, placebo-controlled trial evaluating the safety and efficacy of oral darolutamide in patients with nmCRPC who are currently being treated with ADT and are at high risk for developing metastatic disease. In the clinical study, 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of darolutamide orally twice daily or placebo along with ADT. Patients with a history of seizure were allowed in the study.

Previously published results from the ARAMIS trial demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months for darolutamide plus ADT compared to 18.4 months for placebo plus ADT (p<0.001).(2)

About Nubeqa™ (darolutamide)
Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. The product was approved in March 2020 in the European Union (EU) 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. Nubeqa has also received regulatory approval in several other markets around the world, including the U.S., Brazil, Canada as well as Japan. Filings in other regions are underway or planned.

Nubeqa 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.

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 men (3) 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.


(1) Zurth, Christian; Sandmann, Steffen; Trummel, Dagmar, et al. Higher blood-
brain barrier penetration of [14C]apalutamide and [14C]enzalutamide compared to [14C]Darolutamide in rats using whole-body autoradiography. ASCO GU. Abstract 156. ascopubs.org/doi/abs/10.1200/JCO.2019.37.7_suppl.156.
(2) Williams, Steven; Mazibuko, Ndaba; O'Daly, Owen, et al. Analysis of cerebral blood flow (CBF) in regions relevant to cognitive function with enzalutamide ENZA) compared to darolutamide (DARO) and placebo (PBO) in healthy volunteers. ASCO GU. Abstract 326. ascopubs.org/doi/abs/10.1200/JCO.2020.38.6_suppl.326.
(3) GLOBOCAN 2018: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2018. CA: A Cancer Journal for Clinicians. onlinelibrary.wiley.com/doi/epdf/10.3322/caac.21492.

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 benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 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.


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