KIRKLAND, QC, Aug. 22, 2024
PADCEV plus pembrolizumab approved based on EV-302 trial
KIRKLAND, QC, Aug. 22, 2024 /CNW/ - Pfizer Canada ULC today announced that Health Canada has approved PADCEV® (enfortumab vedotin) an antibody-drug conjugate (ADC) in combination with pembrolizumab, a PD-1 inhibitor, for the treatment of adult patients with unresectable locally advanced or metastatic urothelial cancer (la/mUC) with no prior systemic therapy for mUC.
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The approval was made under the Health Canada Priority Review process, after having met the criteria of substantial evidence of clinical effectiveness providing an improved benefit/risk profile over existing therapies. The approval is based in part on results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39). Findings from EV-302 were presented at the European Society for Medical Oncology (ESMO) 2023 Congress.
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Bladder cancer affects approximately 12,300 Canadians each year and claims the lives of approximately 2,600 Canadians every year.i Urothelial cancer, or bladder cancer, begins in the urothelial cells, which line the urethra, bladder, ureters, and renal pelvis.ii The advanced stages of urothelial cancer are often referred to as locally advanced or metastatic. 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.iii
Srikala Sridhar, MD, Head of the Genitourinary Medical Oncologists of Canada, Professor and Medical Oncologist at the Princess Margaret Cancer Centre, in Toronto"Metastatic urothelial cancer is an aggressive disease with limited treatment options and a poor prognosis. This approval represents an important step forward in the treatment of advanced bladder cancer. This combination of an antibody drug conjugate and immunotherapy in the first-line setting offers new hope for our patients and their families."
Michelle Colero, Executive Director, Bladder Cancer Canada"We are thrilled that Health Canada has approved a new treatment option for advanced bladder cancer, and we are excited about the hope it will provide to members of the bladder cancer patient community. Despite recent advances in the treatment of advanced bladder cancer, there remains an important need for new therapies for patients."
Cynthia Di Lullo, Oncology Lead, Pfizer Canada"Today's Health Canada's approval represents an opportunity to help change the treatment of advanced bladder cancer and provides a new option to the thousands of Canadians impacted by this aggressive disease. At Pfizer, we are committed to improving the lives of Canadians and we are proud of our scientific innovations, including targeted therapies, such as PADCEV, that continue to address and support those living with cancer."
About EV-302The EV-302 trial (also known as KEYNOTE-A39) is an open-label, randomized, controlled Phase 3 study, evaluating enfortumab vedotin in combination with pembrolizumab versus chemotherapy in patients with previously untreated la/mUC. The study enrolled 886 patients with previously untreated la/mUC who were eligible for cisplatin- or carboplatin-containing chemotherapy regardless of PD-L1 status. Patients were randomized to receive either enfortumab vedotin in combination with pembrolizumab, or chemotherapy. The dual primary endpoints of this trial are OS and PFS per RECIST v1.1 by blinded independent central review (BICR). Select secondary endpoints include objective response rate (ORR) and duration of response (DOR) per RECIST v1.1 by BICR, and safety.
About Bladder and Urothelial Cancer
About the Pfizer, Astellas and Merck CollaborationSeagen and Astellas entered a clinical collaboration agreement with Merck to evaluate the combination of Seagen's and Astellas' PADCEV® (enfortumab vedotin) and Merck's KEYTRUDA® (pembrolizumab) in patients with previously untreated metastatic urothelial cancer. As previously announced, Pfizer Inc. successfully completed its acquisition of Seagen Inc. on December 14, 2023. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About Pfizer CanadaPfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. At Pfizer, we apply science and our global resources to bring therapies to people that help extend and improve their lives. We strive to set the standard for quality, safety, and value in the discovery, development, and manufacture of health care products. Every day, Pfizer colleagues work to advance wellness, prevention, treatments, and cures that challenge the most feared diseases of our time. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on LinkedIn, Facebook, X, Instagram or YouTube.
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i Bladder cancer statistics | Canadian Cancer Society. (Updated May 2024)
ii What Is Bladder Cancer? - NCI
iii Prognosis and survival for bladder cancer | Canadian Cancer Society
iv What Is Bladder Cancer? - NCI
v Bladder cancer statistics | Canadian Cancer Society.
vi Bladder Cancer Facts - Bladder Cancer Canada
vii Alimohamed, et al. Understanding treatment patterns and outcomes among patients with de novo unresectable locally advanced ormetastatic urothelial cancer: A Population-Level Retrospective Analysis from Alberta, Canada. Curr Oncol. 2022;29:7587–7597.
viii Risks for bladder cancer | Canadian Cancer Society
SOURCE Pfizer Canada
