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European Commission Approves Astellas’ PADCEVTM (enfortumab vedotin) in Combination with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Urothelial Cancer

August 28, 2024 – Clinical Trials, Drug Discovery, Pharmaceutical – Astellas, European Commission, marketing authorisation, oncology, urothelial cancer

First regimen approved in advanced urothelial cancer to demonstrate superiority to platinum-containing chemotherapy, the standard of care for nearly 40 years
European Marketing Authorization based on positive overall survival and progression-free survival results from the global Phase 3 EV-302 trial

28 August 2024 — Tokyo, Japan — Astellas Pharma Inc today announced that the European Commission has granted Marketing Authorization for PADCEVTM (enfortumab vedotin, an antibody-drug conjugate [ADC]) in combination with KEYTRUDA® (pembrolizumab, a PD-1 inhibitor) for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer, who are eligible for platinum-containing chemotherapy.

The approval is based on results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) which showed that enfortumab vedotin in combination with pembrolizumab nearly doubled median overall survival (OS) and significantly extended progression-free survival (PFS) compared to platinum-containing chemotherapy.

Dr. Thomas Powles, Barts Cancer Institute Biomedical Research Centre, UK
“Having an effective new first-line treatment for advanced urothelial cancer is opening a long-awaited new chapter in the management of this usually fatal disease. The impressive effects of the treatment combination were clearly seen during the Phase 3 clinical trial program, with enfortumab vedotin in combination with pembrolizumab significantly extending overall survival and progression-free survival compared to platinum-containing chemotherapy. I look forward to seeing the treatment combination implemented as a first-line regimen in the clinical setting.”

Alex Filicevas, Executive Director, World Bladder Cancer Patient Coalition “Despite Europe having the highest reported rates of new bladder cancer cases in the world, awareness remains low, resulting in many patients only being correctly diagnosed at the stage of advanced disease. New treatment options are desperately needed to improve disease outcomes for these patients and provide hope for a better future for the whole bladder cancer patient community.”

Ahsan Arozullah, MD, MPH, Senior Vice President and Head of Oncology Development, Astellas “In line with the recent updates to European clinical guidelines, we are delighted that the European Commission has approved enfortumab vedotin in combination with pembrolizumab as first-line treatment for patients with unresectable or metastatic urothelial cancer. This approval is testament to our ongoing partnership with clinical trial investigators, study participants and their families, and the broader bladder cancer community. We look forward to patients across the European Union gaining benefit from this combination early in their treatment journey.”

Bladder cancer is the fifth most commonly diagnosed cancer across the European region. Every year, more than 165,000 people are diagnosed with the disease and it claims the lives of over 50,000 people in the European Union (EU). Diagnosis often comes late, with many patients presenting with advanced or metastatic disease where survival outcomes are particularly poor.

The Phase 3 EV-302 clinical trial explored the efficacy and safety of enfortumab vedotin in combination with pembrolizumab in patients with previously untreated unresectable locally advanced or metastatic urothelial cancer (la/mUC). Results showed that the treatment combination resulted in a median OS of 31.5 months (95% CI: 25.4-NR) compared to 16.1 months (95% CI: 13.9-18.3) with platinum-containing chemotherapy, representing a 53% reduction in risk of death (Hazard Ratio [HR]=0.47; 95% Confidence Interval [CI]: 0.38-0.58; P<0.00001). The median PFS of 12.5 months (95% CI: 10.4-16.6) with the combination compared to 6.3 months (95% CI: 6.2-6.5) with chemotherapy represents a 55% reduction in the risk of cancer progression or death (HR=0.45; 95% CI: (0.38-0.54); P<0.00001). During the EV-302 trial, approximately 30% of patients completed treatment with chemotherapy and then went on to receive maintenance therapy with avelumab, a PD-L1 inhibitor, which is reflective of current real world clinical practice. Results were presented at the 2023 European Society for Medical Oncology (ESMO) Congress and published in the New England Journal of Medicine.

The European Marketing Authorization is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway, and is aligned to recently updated clinical guidelines from the European Society for Medical Oncology and European Association of Urology which recommend enfortumab vedotin in combination with pembrolizumab as first-line treatment for locally advanced or metastatic urothelial cancer. Astellas is working closely with local regulatory authorities and health technology assessment bodies across the EU to ensure that patients who may gain benefit are able to access the treatment combination as soon as possible.

The approval follows the December 2023 approval of enfortumab vedotin in combination with pembrolizumab for the treatment of adult patients with la/mUC by the US Food and Drug Administration (FDA), and the European Commission approval of enfortumab vedotin as a monotherapy for the treatment of adult patients with la/mUC who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor in April 2022.

Astellas has already reflected the impact from this result in its financial forecast for the current fiscal year ending March 31, 2025.

About Astellas
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at www.astellas.com/en.

About the Astellas, Pfizer and MSD Collaboration
Astellas and Pfizer have a clinical collaboration agreement with MSD to evaluate the combination of Astellas’ and Pfizer’s PADCEV™ (enfortumab vedotin) and MSD’s KEYTRUDA® (pembrolizumab) in patients with previously untreated metastatic urothelial cancer. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada).