Pfizer Inc. and Astellas Pharma Inc. have reported positive topline results from the Phase 3 EV-303 (KEYNOTE-905) clinical trial, which evaluated PADCEV™ (enfortumab vedotin) in combination with KEYTRUDA™ (pembrolizumab) as treatment before and after surgery in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or declined cisplatin-based chemotherapy. The combination was compared with surgery alone, the current standard of care.
At the first interim efficacy analysis, the study met its primary endpoint of event-free survival (EFS) and a key secondary endpoint of overall survival (OS), showing statistically significant and clinically meaningful improvement over surgery alone. An additional secondary endpoint, the pathologic complete response (pCR) rate, was also achieved. The trial continues to assess secondary EFS, OS and pCR outcomes for KEYTRUDA monotherapy compared with surgery as the data mature.
Christof Vulsteke, M.D., Ph.D., Head of Integrated Cancer Center Ghent and principal investigator of EV-303, said, “These EV-303 study results mark the first time a systemic treatment approach, used before and after surgery, significantly extended survival over standard-of-care surgery in this population, demonstrating the potential of this combination to address a critical unmet patient need.”
The safety results for both PADCEV plus KEYTRUDA and KEYTRUDA alone were consistent with the known profiles of each treatment. Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Head of Oncology Development at Astellas, said the results represent a potential new treatment approach for cisplatin-ineligible MIBC patients in the neoadjuvant and adjuvant setting.
MIBC accounts for approximately 30 percent of all bladder cancer cases and is considered an aggressive form of the disease, with a high risk of recurrence and spread. Worldwide, bladder cancer is diagnosed in more than 614,000 patients annually. For eligible patients, the standard treatment involves neoadjuvant cisplatin-based chemotherapy followed by surgery, which can extend survival. However, up to half of MIBC patients are not candidates for cisplatin and often undergo surgery alone.
Johanna Bendell, M.D., Oncology Chief Development Officer at Pfizer, noted that PADCEV plus KEYTRUDA is already a standard treatment for locally advanced or metastatic urothelial cancer and that the new data underscore its potential in earlier stages of bladder cancer.
Pfizer and Astellas plan to present the EV-303 results at an upcoming medical congress and discuss them with health authorities for potential regulatory submissions. The combination is also being studied in cisplatin-eligible patients with MIBC in the ongoing Phase 3 EV-304 (KEYNOTE-B15) trial.
PADCEV is a Nectin-4 directed antibody-drug conjugate, while KEYTRUDA is an anti-PD-1 therapy designed to help the immune system target cancer cells. Together, they aim to improve patient outcomes through a combined mechanism of targeted delivery and immune activation.
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