Health Canada approves additional indication for NUBEQA® (darolutamide) for the treatment of metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel

• Today's approval was based on the pivotal Phase III ARASENS trial, which showed a significant overall survival (OS) benefit and favourable tolerability profile with darolutamide plus androgen deprivation therapy (ADT) with docetaxel compared to ADT plus docetaxel
• Darolutamide is the only androgen receptor inhibitor (ARi) approved in combination with docetaxel plus ADT, demonstrating a 32.5% reduction in the risk of death compared to ADT plus docetaxel

MISSISSAUGA, ON, Oct. 5, 2022 /CNW/ - Bayer Inc. announced today that Health Canada, following a priority review, has approved NUBEQA^® (darolutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel¹. 

The approval is based on positive results of the Phase III ARASENS trial that demonstrated darolutamide plus androgen deprivation therapy (ADT) with docetaxel significantly reduced the risk of death by 32.5% compared to ADT plus docetaxel. These results were recently published in The New England Journal of Medicine². NUBEQA^® is approved in more than 70 markets around the world, including the U.S., the European Union (EU), Japan, and China for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease, and received its first approval for mCSPC in the U.S. on August 5, 2022. The compound is also being investigated in further studies across various stages of prostate cancer.

"Prostate cancer at the metastatic stage is, unfortunately, incurable but with standard hormonal therapy patients were able to live for a few years with a good quality of life" said Dr. Fred Saad, MD, FRCSC, Professor and Chief Urology and Director of GU Oncology at the University of Montreal Hospital Centre. "Research has shown that by adding chemotherapy or new generation hormonal therapy to standard hormonal therapy, we were able to improve survival while maintaining quality of life. This recent study now shows that we can further improve the survival of patients with newly diagnosed metastatic prostate cancer by immediately adding darolutamide, a new generation hormonal therapy, to chemotherapy. This combination is well tolerated and does not diminish the quality of lives of these patients and is very welcome news and offers new hope for many patients who are diagnosed with metastatic prostate cancer. For us, who treat these patients, it gives us the opportunity to offer something new and effective to those most in need."

Among those assigned male at birth, it is projected that prostate cancer will remain the most commonly diagnosed cancer, representing about one in five new cancers³. Most patients with mCSPC will progress to CRPC and approximately one in three patients will survive five years from diagnosis ^4,5.

"The ARASENS study demonstrates that NUBEQA^® in combination with docetaxel and ADT significantly improves survival in patients with mCSPC with a favourable safety profile," says Dr. Shurjeel Choudhri, Senior Vice-President and Head of Medical & Scientific Affairs for Bayer Inc. "This latest approval affirms Bayer's commitment to patients across different stages of prostate cancer and offers an important new treatment option for eligible patients."

"The new indication for NUBEQA^® is excellent news for patients with metastatic castration-sensitive prostate cancer," explains Laurent Proulx, President and CEO of PROCURE. "For these men, this approval not only adds a different treatment approach for them and their physicians but could also mean more time spent with loved ones."

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

About the ARASENS Trial 
The ARASENS trial is the only randomized, Phase III, multi-center, double-blind trial which was prospectively designed to compare the use of a second-generation oral androgen receptor inhibitor (ARi), darolutamide, plus ADT and docetaxel to ADT plus docetaxel (a guideline recommended standard-of-care) in metastatic castration-sensitive prostate cancer (mCSPC). A total of 1,306 patients were randomized in a 1:1 ratio to receive 600 mg of darolutamide twice a day or matching placebo, plus ADT and docetaxel.

The primary endpoint of this trial was overall survival (OS). Secondary endpoints included time to castration-resistant prostate cancer (CRPC), time to pain progression, time to first symptomatic skeletal event (SSE), time to initiation of subsequent anticancer therapy, all evaluated at 12–week intervals, as well as adverse events (AEs) as a measure of safety and tolerability. Results from this trial were presented at ASCO GU 2022 and simultaneously published in the New England Journal of Medicine². The ARASENS trial demonstrated that darolutamide plus androgen deprivation therapy (ADT) with docetaxel significantly reduced the risk of death by 32.5% compared to ADT plus docetaxel². Improvements in the secondary efficacy endpoints supported the benefit observed in the primary endpoint, overall survival².

The combination of darolutamide plus ADT with docetaxel resulted in minimal additional adverse events (AEs) compared to docetaxel plus ADT, including any-grade, Grade 3 to 5, and serious AEs. Permanent discontinuation due to adverse reactions occurred were similar for the two treatment groups.

About Metastatic Castration-Sensitive Prostate Cancer
In 2022, approximately 24,600 adults in Canada will be 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 deaths annually⁶. 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.

At the time of initial diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. Upon relapse, the disease may metastasize or spread and may be hormone-sensitive (also known as castration-sensitive). In some cases, patients may be diagnosed as metastatic and castration-sensitive disease from the start. Current systemic treatment options for men with metastatic castration-sensitive prostate cancer (mCSPC) include ADT, androgen receptor pathway inhibitors, docetaxel (chemotherapy) or a combination of some of these therapies. Despite these treatments, a large proportion of men with mCSPC will eventually experience progression to metastatic castration-resistant prostate cancer (mCRPC), a condition with high morbidity and reduced survival.

About NUBEQA^® (darolutamide) 
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. Studies indicate 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 extent¹. 

The product is approved under the brand name NUBEQA^® in more than 70 markets around the world, including the U.S., Canada, EU, Japan, and China, for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. The compound is also being investigated in studies across various stages of prostate cancer.

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 extends to five marketed products with several other therapies in various stages of clinical development, including a unique approach of advancing targeted alpha therapies for prostate cancer. 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 drive sustainable development and generate 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 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 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.

For a Plain Language Summary of the ARASENS Trial
Visit FutureMedicine.com at https://www.futuremedicine.com/doi/full/10.2217/fon-2022-0433?rfr_dat=cr_pub++0pubmed&url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org.

Reference

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^1	NUBEQA^® Product Monograph, https://www.bayer.com/sites/default/files/2020-11/nubeqa-pm-en.pdf, September 28, 2022.
^2	Smith M., Hussain M., Saad F. et al. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022
^3	Siegel DA, O'Neil ME, Richards TB, Dowling NF, Weir HK. Prostate Cancer Incidence and Survival, by Stage and Race/Ethnicity — United States, 2001–2017. MMWR Morb Mortal Wkly Rep 2020;69:1473–1480. http://dx.doi.org/10.15585/mmwr.mm6941a1.
^4	Ng, K., Smith, S., Shamash, J. Metastatic Hormone-Sensitive Prostate Cancer (mHSPC): Advances and Treatment Strategies in the First-Line Setting. Oncol Ther 8, 209–230 (2020). https://doi.org/10.1007/s40487-020-00119-z.
^5	Hahn AW, Higano CS, Taplin ME, Ryan CJ, Agarwal N. Metastatic Castration-Sensitive Prostate Cancer: Optimizing Patient Selection and Treatment. Am Soc Clin Oncol Educ Book. 2018 May 23;38:363-371. https://doi.org/10.1200/edbk_200967.
^6	Canadian Cancer Society, https://www.cancer.ca/en/cancer-information/cancer-type/prostate/statistics/?region=on, accessed February 12, 2020.

SOURCE Bayer Inc.

Bayer Inc., Communications Department, [email protected]