Updated results of Phase III trial show darolutamide plus androgen deprivation therapy significantly increased overall survival in men with non-metastatic castration-resistant prostate cancer

February 13, 2020

Updated results of Phase III trial show darolutamide plus androgen deprivation therapy significantly increased overall survival in men with non-metastatic castration-resistant prostate cancer

Full data to be presented at upcoming scientific meeting
Not intended for U.S. and UK media

Mississauga, ON, February 12, 2020 – Results from the preplanned final overall survival analysis of the Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial that investigated darolutamide in men with non-metastatic castration-resistant prostate cancer (nmCRPC) show a statistically significant improvement in overall survival (OS) in patients receiving darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT. Previously published results from ARAMIS show a statistically significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS) of darolutamide plus ADT compared to placebo plus ADT. Detailed data on the updated OS and other additional endpoints as well as an update on longer-term safety will be presented at an upcoming scientific meeting.

Darolutamide, a non-steroidal androgen receptor axis targeted (ARAT) therapy, has been approved in the U.S., Brazil and Japan, under the brand name NUBEQA^® and filings in the European Union and other regions are underway or planned. The compound is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

About the ARAMIS trial

The ARAMIS trial is 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.

About darolutamide

Darolutamide is an orally administered, non-steroidal androgen receptor (AR) inhibitor 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 http://www.clinicaltrials.gov.

Darolutamide has been approved in the U.S., Brazil and Japan under the brand name NUBEQA® and has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) for marketing authorization in Europe.

Prostate cancer is the most common cancer among Canadian men (excluding non-melanoma skin cancers). It is the third leading cause of death from cancer in men in Canada.^[1] In 2019, approximately 22,900 men were diagnosed with prostate cancer, representing 20% of all new cancer cases in men. Each year more than 4,100 die from prostate cancer.^[2] Prostate cancer results from the abnormal proliferation of cells within the prostate gland, which is part of a man’s reproductive system. It mainly affects men over the age of 50, and the risk increases with age.

Treatment options range from surgery to radiation treatment to therapy using hormone-receptor antagonists, i.e., substances that stop the formation of testosterone or prevent its effect at the target location. However, in nearly all cases, the cancer eventually becomes resistant to conventional hormone therapy.

CRPC is an advanced form of the disease where the cancer keeps progressing despite ADT treatment, even when the amount of testosterone is reduced to very low levels in the body. In men with progressive nmCRPC, a rapid PSA doubling time has been consistently associated with reduced time to first metastasis and death.

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer in Canada now expands to four marketed products and several other therapies in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

Bayer: Science For A Better Life

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 2018, the Group employed around 117,000 people and had sales of 39.6 billion euros. Capital expenditures amounted to 2.6 billion euros, R&D expenses to 5.2 billion euros. For more information, go to www.bayer.ca.

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.