- PADCEV plus Keytruda is the first and only regimen without platinum-based chemotherapy to improve event-free and overall survival when used before and after surgery in cisplatin-eligible patients with muscle-invasive bladder cancer
- Positive EV-304 data, combined with the recent unprecedented results from the EV-303 trial, highlight the potential of this combination to become a new platinum-free standard of care in an earlier stage of bladder cancer
- Results from the Phase 3 EV-304 trial will be presented at an upcoming medical meeting and discussed with global health authorities for potential regulatory filings
An additional secondary endpoint of pathologic complete response (pCR) rate for neoadjuvant PADCEV plus pembrolizumab versus neoadjuvant chemotherapy was also met, and a clinically meaningful and statistically significant improvement was observed. The safety profile for PADCEV plus pembrolizumab was consistent with the known profile of the treatment regimen.
Christopher Hoimes, DO, Director of the Bladder Cancer Program and Center for Cancer Immunotherapy at Duke Cancer Institute, an EV-304 Principal Investigator
“Despite available treatment options, nearly half of patients with muscle-invasive bladder cancer progress to metastatic disease within three years of diagnosis. The EV-304 results represent a key milestone in the new era of urothelial cancer treatment. Together, the EV-303 and EV-304 results show that perioperative enfortumab vedotin plus pembrolizumab can positively impact the treatment journey for patients with muscle-invasive bladder cancer, offering significant survival gains across cisplatin-ineligible and cisplatin-eligible patients, signaling a shift from conventional platinum-based chemotherapy and the potential to transform the standard of care.”Moitreyee Chatterjee-Kishore, PhD, MBA, Head of Oncology Development, Astellas
“Building on the recent U.S. approval for cisplatin-ineligible patients living with MIBC, these positive EV-304 findings reinforce the potential of PADCEV plus pembrolizumab to improve survival outcomes for a broad population of patients living with muscle-invasive bladder cancer. Together with the EV-303 data, these results strengthen the evidence supporting this combination regimen as a treatment option for patients regardless of cisplatin eligibility. We are committed to bringing forth much-needed advancements and hope to more patients.”
Jeff Legos, PhD, MBA, Chief Oncology Officer, Pfizer
“For the first time, patients with muscle-invasive bladder cancer are seeing significant survival benefits from combination therapy in a perioperative setting without the need for platinum-based chemotherapy, signaling the potential for a new standard of care for this community. The EV-304 results, combined with the recent unprecedented results from the EV-303 trial, showcase the promising future of this regimen as a cornerstone of care for bladder cancer regardless of cisplatin eligibility.”
Bladder cancer is the ninth most common cancer worldwide, diagnosed in more than 614,000 patients each year globally, including an estimated 85,000 people in the U.S.i,ii MIBC represents approximately 30% of all bladder cancer cases.iii The standard treatment for eligible patients with MIBC is neoadjuvant cisplatin-based chemotherapy followed by surgery.iv However, even after undergoing surgery, half of patients with MIBC experience disease recurrence.v
PADCEV plus pembrolizumab is not currently approved for use as neoadjuvant and adjuvant treatment in cisplatin-eligible patients with MIBC. These results will be submitted for presentation at an upcoming medical congress and will be discussed with global health authorities for potential regulatory filings.
PADCEV plus pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph was recently approved by the U.S. Food and Drug Administration in cisplatin-ineligible patients with MIBC, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment based on results from the Phase 3 EV-303 clinical trial (also known as KEYNOTE-905).
Source: Astellas Pharma Inc. (2025). PADCEV™ Plus Keytruda® Significantly Improves Survival for Patients with Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility [Press release]. https://www.pfizer.com/news/press-release/press-release-detail/padcevtm-plus-keytrudar-significantly-improves-survival?cid=em_PfizerNewsroomAlert&ttype=em.