The European Medicines Agency (EMA) validated a Type II variation application for PADCEV® (enfortumab vedotin) in combination with KEYTRUDA® (pembrolizumab) as a first-line therapy for adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). If approved, this combination therapy could revolutionize the treatment landscape by offering an alternative to platinum-containing chemotherapy, the current standard of care for urothelial cancer.
Bladder cancer is a global concern, with approximately 573,000 new cases and 212,000 deaths reported annually. In Europe alone, about 200,000 people are diagnosed with bladder cancer each year. The need for innovative and effective treatments in the European market is evident.
Dr. Roger Dansey, Chief Development Officer, Oncology at Pfizer, emphasized the importance of this combination therapy, especially for patients facing poor outcomes at the advanced stage of bladder cancer. Innovative therapies that extend survival and improve outcomes are essential, and the acceptance of this application brings us closer to achieving that mission. Ahsan Arozullah, Senior Vice President and Head of Oncology Development at Astellas echoed the sentiment that patients in Europe require better treatment options for advanced-stage urothelial cancer. The potential approval of enfortumab vedotin and pembrolizumab as a combination therapy represents a milestone and a commitment to helping patients with advanced urothelial cancer live longer healthier lives.
PADCEV and Pembrolizumab Combo Advances in European Regulatory Process
The Type II variation application is grounded in the results of the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39), which demonstrated the effectiveness of combining PADCEV with pembrolizumab for advanced bladder cancer. This combination showed significant improvements in overall survival (OS) and progression-free survival (PFS) compared to platinum-containing chemotherapy. These results are not only statistically significant but also clinically meaningful. Importantly, the safety profile of the combination therapy remained consistent with previous data, with no new safety concerns identified.
The next steps involve the EMA’s Committee for Medicinal Products for Human Use (CHMP) and the European Commission (EC), which are expected to provide their opinions and decisions on the Type II variation application in the calendar year 2024. In the United States, the combination therapy was already approved by the Food and Drug Administration (FDA) in December 2023.
Key Findings from Pivotal Phase 3 Trial of Urothelial Cancer Combination Therapy
The EV-302 trial, a pivotal Phase 3 study, enrolled 886 patients with previously untreated locally advanced or metastatic urothelial cancer. These patients were eligible for cisplatin- or carboplatin-containing chemotherapy, regardless of their PD-L1 status. The trial compared enfortumab vedotin in combination with pembrolizumab to platinum-containing chemotherapy. The primary endpoints included overall survival (OS) and progression-free survival (PFS), both of which showed statistically significant and clinically meaningful improvements with the combination therapy.
In summary, the validation of the Type II variation application for PADCEV and KEYTRUDA as a combination therapy for advanced bladder cancer represents a promising step toward offering patients an alternative to platinum-containing chemotherapy. Bladder cancer patients in Europe may soon have access to an innovative treatment option that could improve their overall survival and quality of life.
Resource: Pfizer, January 26, 2024
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