- Submission based on statistically significant event-free and overall survival data from the Phase 3 EV-304 trial
- Building on the existing indication in cisplatin-ineligible muscle-invasive bladder cancer (MIBC), if approved, this regimen would be the first and only perioperative treatment for patients with MIBC regardless of cisplatin eligibility, marking a potential new standard of care
Moitreyee Chatterjee-Kishore, PhD, MBA, Head of Oncology Development, Astellas "The data from the EV-304 trial take us another step closer to bringing perioperative enfortumab vedotin plus pembrolizumab to patients with muscle-invasive bladder cancer regardless of cisplatin eligibility, who still face a recurrence rate of more than fifty percent despite curative-intent surgery, highlighting the ongoing need for improved treatment strategies."Jeff Legos, PhD, MBA, Chief Oncology Officer, Pfizer
"For people with muscle‑invasive bladder cancer, surgery is often just the beginning of a long and uncertain journey, with far too many patients seeing their cancer return. If approved, perioperative PADCEV plus pembrolizumab could meaningfully change that experience, potentially helping patients reduce the risk of recurrence and live longer, regardless of whether they are eligible for cisplatin."
The sBLA submission was based on data from the Phase 3 EV-304 clinical trial (also known as KEYNOTE-B15), evaluating perioperative enfortumab vedotin in combination with pembrolizumab in patients with MIBC eligible for cisplatin-containing chemotherapy. Results from EV-304, presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), showed a 47% reduction in the risk of tumor recurrence, progression or death and a 35% reduced risk of death for perioperative enfortumab vedotin in combination with pembrolizumab compared to standard of care neoadjuvant (before surgery) gemcitabine and cisplatin chemotherapy.ii The combination also demonstrated a pathological complete response (pCR) rate of 55.8% compared with 32.5% pCR rate in the chemotherapy arm at the time of surgery.ii
The safety profile for perioperative enfortumab vedotin plus pembrolizumab observed in EV-304 was consistent with prior experience with the combination and there were no new safety signals.ii These data will be discussed with additional global health authorities for potential regulatory filings.
- Priority Review. US FDA. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review. Accessed February 24, 2026.
- Neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab for participants with muscle-invasive bladder cancer who are eligible for cisplatin: randomized, open-label, phase 3 KEYNOTE-B15 study. Abstract #LBA630. 2026 American Society of Clinical Oncology Genitourinary (ASCO GU) Congress.
Related Content:
EAU 2026: Neoadjuvant and Adjuvant Enfortumab Vedotin + Pembrolizumab for Patients with Muscle Invasive Bladder Cancer Who Are Eligible for Cisplatin: Pathological and Surgical Outcomes in KEYNOTE-B15