Health Canada Approves XTANDI® (enzalutamide), for the treatment of metastatic castration-sensitive prostate cancer (mCSPC)¹

XTANDI^® is the first and only androgen receptor-axis-targeted therapy (ARAT) approved by Health Canada in three clinical disease states of prostate cancer across four indications²

MARKHAM, ON, June 16, 2020 /CNW/ - Astellas Pharma Canada, Inc., announced that Health Canada, following a Priority Review, has approved XTANDI^® (enzalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).³ Regardless of an mCSPC patient's risk or disease volume, they may benefit from enzalutamide.⁴

Prostate cancer is the most common cancer to affect Canadian men (excluding non-melanoma skin cancers) and is the third most common cause of cancer deaths.⁵ While early prostate cancer is highly treatable,⁶ advanced or metastatic prostate cancer (where the disease has spread beyond the prostate) remains incurable.⁷

"Metastatic castration-sensitive prostate cancer has a particularly poor prognosis – with a median survival of about three to four years," says Dr. Fred Saad, MD, FRCSC, Professor and Chief of Urology and Director of G-U Oncology at the University of Montreal Hospital Centres. "With this approval, I now have an additional option to treat mCSPC patients at the first sign of metastatic disease with a therapy that is backed by longstanding clinical data."

Metastatic castration-sensitive prostate cancer is a disease in which men have prostate cancer that has spread beyond the prostate, and who have never received, or still respond to androgen deprivation therapy (ADT).^8,9  While ADT is initially effective in most patients, progression is inevitable, demonstrating the need for treatment options in addition to ADT.¹⁰ Often men with mCSPC are diagnosed de novo with metastatic disease, meaning that their cancer had spread beyond the prostate prior to it being detected by a physician. In 2018, eight per cent of prostate cancer patients or 1,200 Canadians were diagnosed with de novo metastatic prostate cancer.¹¹

"Over 11,000 Canadian patients have benefited from XTANDI since it was first approved in Canada in 2013.¹² Since then, we've maintained a strong focus and commitment to delivering value and expanding treatment options for men who've been diagnosed with prostate cancer," said Frank Stramaglia, General Manager, Astellas Pharma Canada. "With this new indication, we are proud that we are able to help even more prostate cancer patients and their families."

About XTANDI^®'s (enzalutamide) Approval
The approval for the new indication was based on results from the pivotal Phase 3 ARCHES trial investigating enzalutamide in men with mCSPC.¹³ The ARCHES trial demonstrated that enzalutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiographic progression or death by 61% versus placebo plus ADT in men with mCSPC (n=1,150; hazard ratio [HR]=0.39 [95% confidence interval (CI): 0.30-0.50]; P<0.0001).¹⁴

A total of 41 Canadian patients were enrolled in the ARCHES trial, which had total participation of 1150 patients.¹⁵ There were 13 trial sites in Canada, including locations in Ontario, British Columbia, Alberta and Quebec.¹⁶

About the ARCHES trial
The Phase 3, randomized, double-blind, placebo-controlled, multi-national trial enrolled 1,150 patients with mCSPC.¹⁷ Patients were randomized to receive enzalutamide 160 mg daily or placebo and continued on a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist or had a history of bilateral orchiectomy.¹⁸

The primary endpoint of the trial was radiographic progression-free survival (rPFS), defined as the time from randomization to the first objective evidence of radiographic disease progression as assessed by central review, or death, whichever occurs first.¹⁹

Adverse events in the ARCHES trial were generally consistent with those reported in prior enzalutamide trials.²⁰

About XTANDI^® (enzalutamide)
Enzalutamide is an androgen receptor inhibitor that acts on several steps in the androgen receptor signaling pathway. Enzalutamide competitively inhibits binding of androgens to androgen receptors and, as a result, inhibits translocation of androgen receptors and association of androgen receptors with DNA. By inhibiting the binding of androgens to androgen receptors, enzalutamide treatment decreases the proliferation and induces cell death of prostate cancer cells and decreases tumour volume.²¹

Enzalutamide was first approved by Health Canada in 2013 for patients with metastatic castration-resistant prostate cancer (mCRPC) in men who received prior chemotherapy (docetaxel). Since then, enzalutamide has received indications for mCRPC in men who are chemotherapy naïve (2015) and in men with non-metastatic castration-resistant prostate cancer (2018).

About Astellas Pharma Canada, Inc.
Astellas Pharma Canada, Inc., headquartered in Markham, ON, is a Canadian affiliate of Tokyo-based Astellas Pharma Inc. In Canada, Astellas has an intense commercial focus on three therapeutic areas – Oncology, Immunology and Urology. For more information about Astellas Pharma Canada, Inc., please visit astellas.com/ca.

Dr. Fred Saad was not compensated for any media work. He has been a paid consultant to Astellas Pharma Canada, Inc.

References
^1 XTANDI Product Monograph; June 1, 2020.
^2 XTANDI Product Monograph; June 1, 2020.
^3 XTANDI Product Monograph; June 1, 2020.
^4 Armstrong, A., et al. ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer. Journal of Clinical Oncology. Vol. 37, No 32 (Nov 10, 2019) 2974-2986. https://ascopubs.org/doi/full/10.1200/JCO.19.00799
^5 Canadian Cancer Society. Prostate Cancer Statistics. Available at: https://www.cancer.ca/en/cancer-information/cancer-type/prostate/statistics/?region=on. [Accessed April 2020].
^6 Canadian Cancer Society. Survival Statistics. Available at: https://www.cancer.ca/en/cancer-information/cancer-type/prostate/prognosis-and-survival/survival-statistics/?region=on [Accessed April 2020].
^7 So, A.I., et al. Canadian Urological Association-Canadian Urologic Oncology Group guideline on metastatic castration-naive and castration-sensitive prostate cancer. Canadian Urological Association Journal. 14, 2 (Dec. 2019), 17-23. DOI:https://doi.org/10.5489/cuaj.6384.
^8 Uro Today. Treatment Advances in Metastatic Hormone-Sensitive Prostate Cancer. Available at: https://www.urotoday.com/library-resources/mhspc/111513-treatment-advances-in-metastatic-hormone-sensitive-prostate-cancer-mhspc.html. [Accessed April 2020].
^9 American Society of Clinical Oncology. ASCO Answers: Prostate Cancer (2018). Available at: http://www.cancer.net/sites/cancer.net/files/asco_answers_guide_prostate.pdf. [Accessed April 2020].
^10 So, A.I., et al. Canadian Urological Association-Canadian Urologic Oncology Group guideline on metastatic castration-naive and castration-sensitive prostate cancer. Available at: https://www.cua.org/themes/web/assets/files/6384_revised.pdf [Accessed April 2020]
^11 So, A.I., et al. Canadian Urological Association-Canadian Urologic Oncology Group guideline on metastatic castration-naive and castration-sensitive prostate cancer. Available at: https://www.cua.org/themes/web/assets/files/6384_revised.pdf [Accessed April 2020]
^12 Astellas Pharma Canada Data on File (February 2020)
^13 XTANDI Product Monograph; June 1, 2020.
^14 XTANDI Product Monograph; June 1, 2020.
^15 Astellas Pharma Canada Data on File (February 2020)
^16 Astellas Pharma Canada Data on File (February 2020)
^17 XTANDI Product Monograph; June 1, 2020.
^18XTANDI Product Monograph; June 1, 2020.
^19 XTANDI Product Monograph; June 1, 2020.
^20 XTANDI Product Monograph; June 1, 2020.
^21 XTANDI Product Monograph; June 1, 2020.

SOURCE Astellas Pharma Canada, Inc.

Amanda Mills Sirois, Senior Communications Manager, Astellas Pharma Canada, Inc., 905-940-5752, [email protected]; James Thayer, Proof Inc., 416-969-2766, [email protected]