Seagen Canada Announces Availability of PADCEV® to Treat Advanced Bladder Cancer

• PADCEV represents a targeted therapy directed against Nectin-4, a protein highly expressed in certain types of solid tumours, including urothelial carcinoma¹
  
  
• PADCEV is a therapy approved by Health Canada with a demonstrated improvement in overall survival for patients previously treated with platinum-based chemotherapy and immunotherapy²
  
  
• A recent survey found the majority of Canadians are unaware that bladder cancer has one of the highest recurrence rates³

MISSISSAUGA, ON, Jan. 25, 2022 /CNW/ - Today, Seagen Canada announced the commercial availability of PADCEV^® (enfortumab vedotin) for the treatment of adult patients with unresectable locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and programmed cell death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor therapy.²

Bladder Cancer in Canada Infographic (CNW Group/Seagen)

Bladder cancer affects an estimated 12,000 Canadians each year making it the fifth leading cancer diagnosis in Canada.⁴ Bladder cancer is a disease where cancer cells form in the tissues of the bladder⁵. Urothelial cancer is the most common type of bladder cancer, accounting for about 90 per cent of all cases.⁶ The advanced stages of urothelial cancer are often referred to as locally advanced or metastatic.⁷ Although some locally advanced or metastatic bladder cancers will stop growing, shrink, or even disappear in response to current treatment options, the cancer almost always returns and grows aggressively, shortening life expectancy.⁸ 

"Metastatic urothelial cancer is an aggressive disease with limited treatment options and a poor prognosis," says Dr. Srikala Sridhar, MD, Head of the Genitourinary Medical Oncologists of Canada, Professor and Medical Oncologist at the Princess Margaret Cancer, in Toronto. "PADCEV is the first drug beyond chemotherapy and immunotherapy to show a significant survival benefit in metastatic urothelial cancer and as such represents an important therapeutic advance in the field."

The Heath Canada approval of PADCEV was based on an open–label, randomized, phase 3, multicenter study (EV 301) that enrolled 608 patients (including 52 Canadians) with unresectable locally advanced or metastatic urothelial cancer who received prior treatment with a platinum–containing chemotherapy and PD–1 or PD–L1 inhibitor, a type of immunotherapy.²  At median follow-up of approximately 11 months, compared with chemotherapy, enfortumab vedotin met its primary endpoint and improved overall survival (OS) by almost four months (median 12.88 months versus 8.97 months).²

"We've seen first-hand how more treatment options can improve the quality of life for those living with metastatic or advanced bladder cancer," says Michelle Colero, Executive Director, Bladder Cancer Canada. "We are particularly pleased about the approval of enfortumab vedotin as this new treatment alternative offers patients the opportunity to make plans for their future, while dealing with their diagnosis and treatment today."

A recent Seagen Canada survey gauging Canadian's knowledge of bladder cancer, conducted by Leger Research, found that many Canadians have limited knowledge as it relates to the condition. Key survey learnings included:³

• less than one third (31%) of respondents knew smoking was a risk factor for bladder cancer;
• most respondents (89%) are unaware that bladder cancer has one of the highest recurrence rates among all cancers;
• the majority of respondents (60%) did not know that certain occupations, such as painter, plumber or firefighter, can pose a higher risk for developing bladder cancer; and
• only four-in-ten (42%) respondents know that bladder cancer is a treatable cancer, relative to some other forms of cancer.

"Seagen is proud of our transformative scientific discoveries that continue to address and support those who live with cancer," says Sandra Heller, General Manager of Seagen Canada Inc. "PADCEV represents our dedication to improving the lives of patients through innovative targeted therapies."

About Bladder Cancer
Caught early, a bladder cancer prognosis is excellent for most patients. Caught late, it can be a life-altering or life-ending disease. Once diagnosed, lifetime urology check-ups will be required. Risk factors for bladder cancer include smoking, over 50 years of age and occupational exposures. It also impacts men more than women.⁹ People with bladder cancer which has spread to other parts of the body (about 10-15% of patients¹⁰) have a poor prognosis, with only about 5% living for five years after diagnosis.¹¹                     

About PADCEV²
PADCEV is an antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer. Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).

For more information, please refer to the product monograph for PADCEV located here.

About Seagen
Seagen is a global biotechnology company that discovers, develops, and commercializes transformative cancer medicines to make a meaningful difference in people's lives. Seagen is headquartered in the Seattle, Washington area, and has locations in California, Canada, Switzerland, and the European Union. For more information, visit www.seagen.ca and follow @SeagenGlobal on Twitter.

References

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1	Rosenberg JE, O'Donnell PH, Balar AV, et al. Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy. J Clin Oncol 2019;37(29):2592-600. Available at: https://pubmed.ncbi.nlm.nih.gov/31356140/
2	PADCEV^® (enfortumab vedotin) Canada Product Monograph. October 29, 2021. Available at: https://seagen.ca/assets/pdfs/PADCEV_PM_29OCT21_v2.0.pdf
3	Leger Research (2021); Seagen Canada Omnibus Survey.
4	Bladder Cancer Canada.  Bladder Cancer Facts.  Available at: https://bladdercancercanada.org/en/bladder-cancer-facts/
5	American Society of Clinical Oncology. Bladder cancer: introduction. https://www. cancer.net/cancer-types/bladder-cancer/introduction . Accessed 05-09-2019.
6	Canadian Cancer Society. Urothelial Cancer. Available at: https://cancer.ca/en/cancer-information/cancer-types/bladder/what-is-bladder-cancer/cancerous-tumours
7	National Cancer Institute. Bladder Cancer. https://www.cancer.gov/types/bladder/patient/bladder-treatment-pdq#:~:text=Bladder%20cancer%20is%20a%20disease,to%20help%20diagnose%20bladder%20cancer. Accessed November 10, 2021.
8	Canadian Cancer Society. Urothelial Cancer. Available at: https://cancer.ca/en/cancer-information/cancer-types/bladder/what-is-bladder-cancer/cancerous-tumours
9	Government of Canada. Bladder cancer in Canada. https://www.canada.ca/en/public-health/services/publications/diseases-conditions/bladder-cancer-canada.html. Accessed November 10, 2021.
10	Bladder Cancer Canada. Types of Bladder Cancer. Available at: https://bladdercancercanada.org/en/bladder-cancer-definitions/.
11	National Cancer Institute. Study Clarifies Timing of Immunotherapy for Advanced Bladder Cancer. Available at: https://www.cancer.gov/news-events/cancer-currents-blog/2020/avelumab-bladder-cancer-maintenance-therapy

SOURCE Seagen

Emma Gilbert, Seagen International, [phone], [email protected]