February 25, 2020

New treatment for men with non-metastatic castration resistant prostate cancer approved in Canada

MISSISSAUGA, ON, February 25, 2020 – Bayer Inc. is pleased to announce that Health Canada has issued a Notice of Compliance for NUBEQA® (darolutamide tablets), a non-steroidal androgen receptor (AR) inhibitor therapy, for the treatment of patients with non-metastatic castration resistant prostate cancer (nmCRPC).

The Canadian approval of NUBEQA®  was based on the Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial evaluating darolutamide plus androgen deprivation therapy (ADT), which demonstrated a significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months versus 18.4 months for placebo plus ADT (p<0.000001). 

“The treatment of advanced prostate cancer has had an unparalleled progress over the past decade. In spite of this, many treatment gaps continue to exist,” says Dr. Ricardo Rendon, Professor and Director of Research, Department of Urology Medical Advisory and Research Board, Dalhousie University; Chair, Genitourinary Cancer Site Team; and VP Education, Canadian Urological Association. “We welcome the addition of NUBEQA® to our treatment portfolio in Canada for the management of non-metastatic castrate resistant prostate cancer. This medication has shown excellent results from a cancer control point of view while maintaining the quality of life of our patients and facilitating the work of health care providers with its ease of use.”

In 2019, approximately 22,900 Canadian men were diagnosed with prostate cancer, representing 20 per cent of all new cancer cases.[i] Prostate cancer that is treated with ADT but keeps progressing even when the amount of testosterone is reduced to very low levels in the body is known as castration resistant prostate cancer (CRPC). One third of patients with non-metastatic CRPC will develop metastases within 2 years, increasing their risk of symptoms and mortality.[ii] Generally, men with nmCRPC are asymptomatic but have a rising prostate specific antigen (PSA).[iii]

Metastasis-free survival was further supported by a delay in the other secondary endpoints of time to pain progression, time to cytotoxic chemotherapy and time to symptomatic skeletal event, in the darolutamide plus ADT group versus placebo plus ADT. Detailed updated analyses on OS and other secondary endpoints and safety results from the ARAMIS trial, will be presented at an upcoming scientific congress.

The only adverse reactions occurring more frequently in the darolutamide plus ADT arm (≥2% absolute increase in frequency) over placebo plus ADT were fatigue (15.8% vs. 11%), pain in extremity (6% vs. 3%), and rash (3% vs. 1%). Permanent discontinuation due to adverse reactions occurred in approximately 9 per cent of patients in both arms of the study.[iv]

“Those with prostate cancer need access to more treatment options that offer a better quality of life, prevent their cancer from spreading and delay the need for more aggressive therapies,” says Dr. Stuart Edmonds, Executive Vice President of Mission at the Canadian Cancer Society. “We welcome the addition of new treatment options that help improve the cancer experience and allow people to live longer, healthier lives, while leaving the window open for new therapies to come onto the market.”

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

Dr. Shurjeel Choudhri, Senior Vice President and Head, Medical and Scientific Affairs for Bayer Inc., remarks, “Treatment options that are proven safe and effective at slowing the progression of the disease, while tolerable from a side-effect profile, are critical for patients with non-metastatic castration resistant prostate cancer. The approval of NUBEQA® provides a new and viable treatment option for these patients.”

About the ARAMIS trial

The ARAMIS trial is a randomized (2:1), double-blind, placebo-controlled, multi-center Phase III study which evaluated the safety and efficacy of the compound in patients with nmCRPC who are currently being treated with androgen deprivation therapy (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, or conditions predisposing to seizure, were not excluded from the study.[v]

The primary endpoint of MFS in ARAMIS is defined as the time from randomization to the time of first evidence of blinded independent central review (BICR)-confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first.

Ten Canadian sites participated in the ARAMIS trial.

About darolutamide

Darolutamide is an androgen receptor (AR) inhibitor with a distinct chemical structure that competitively inhibits androgen binding and therefore the growth of prostate cancer cells. Preclinical studies showed that darolutamide has a lower blood-brain barrier penetration compared to other currently available AR inhibitors.[vi] This indicates low passage of darolutamide across the intact blood-brain barrier in rats and mice and a low likelihood that darolutamide crosses the intact blood-brain barrier in humans to a clinically relevant extent.[vii]

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.

About castration resistant prostate cancer (CRPC)

In 2019, approximately 22,900 men in Canada were diagnosed with prostate cancer, representing 20% of all new cancer cases in men. Prostate cancer is the most common cancer among Canadian men (excluding non-melanoma skin cancers) and is the third leading cause of death from cancer in men in Canada, resulting in more than 4,100 men deaths annually.[viii] Prostate cancer results from the abnormal proliferation of cells within the prostate gland, which is part of a man’s reproductive system. Over time, it can progress and spread to other parts of the body, such as lymph nodes and bones. 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 ADT, 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. The field of treatment options for castration resistant patients is evolving rapidly. Until two years ago, there had been no treatment options approved by Health Canada for patients who have rising prostate-specific antigen (PSA) levels while on ADT and no detectable metastases, nmCRPC. 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 five marketed products with 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.

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[i] Canadian Cancer Society: https://www.cancer.ca/en/cancer-information/cancer-type/prostate/statistics/?region=on accessed February 12, 2020

[ii] Kirby M, et al. Int J Clin Pract. 2011;65:1180–1192

[iii] Mateo J et al. Eur Urol. 2019;75:285–293

[iv] NUBEQA® product monograph: https://www.bayer.ca/omr/online/nubeqa-pm-en.pdf

[v] Fizazi K, et al. N Engl J Med. 2019;380:1235–1246

[vi] Moilanen A, et al. Sci Rep 2015;5:12007

[vii] NUBEQA® product monograph: https://www.bayer.ca/omr/online/nubeqa-pm-en.pdf

[viii] Canadian Cancer Society: https://www.cancer.ca/en/cancer-information/cancer-type/prostate/statistics/?region=on accessed February 12, 2020