PADCEV and Keytruda reduce risk of recurrence/death by nearly 50% in cisplatin eligible muscle invasive bladder cancer

Pfizer and Astellas Pharma has recently announced their new positive results from the Phase 3 EV-304 clinical trial for PADCEVwhich is a Nectin-4 directed antibody-drug conjugate, in combination with Keytruda, a PD-1 inhibitor, in patients with muscle-invasive bladder cancer eligible for cisplatin-based chemotherapy. Perioperative enfortumab vedotin plus pembrolizumab demonstrated a 47% reduction in the risk of tumor recurrence, progression or death compared to patients treated with standard of care neoadjuvant gemcitabine and cisplatin.

Christopher Hoimes, DO, Director of the Bladder Cancer Program and Center for Cancer Immunotherapy at Duke Cancer Institute, and an EV-304 Principal Investigator

“Approximately half of patients with muscle-invasive bladder cancer experience disease recurrence even after having their bladder removed. The EV-304 results, combined with the EV-303 study, provide compelling evidence that perioperative enfortumab vedotin plus pembrolizumab may offer survival benefits in the curative setting for patients with muscle-invasive bladder cancer, highlighting a potential departure from platinum-based chemotherapy as a cornerstone of care.”

Overall survival was a key secondary endpoint in EV-304 and showed a 35% reduced risk of death in patients treated with perioperative enfortumab vedotin plus pembrolizumab versus neoadjuvant chemotherapy. The combination also demonstrated a pathological complete response rate of 55.8% compared with 32.5% pCR rate at the time of surgery, indicating that more than half of patients treated with the combination had no detectable disease at the time of surgery.In addition, EFS, OS and pCR benefits were generally consistent across all pre-defined subgroups, including age, gender, PD-L1 status, clinical stage and geographic region.

Jeff Legos, PhD, MBA, Chief Oncology Officer, Pfizer

“For people with muscle‑invasive bladder cancer, a perioperative approach that avoids the need for platinum‑based chemotherapy has demonstrated significant survival benefits. These compelling data, reinforced by the unprecedented EV‑303 results, suggest a transformative opportunity to establish PADCEV plus pembrolizumab as the next standard of care if approved, and provide a meaningful step forward for patients and their families.”

Moitreyee Chatterjee-Kishore, PhD, MBA, Head of Oncology Development, Astellas

“The EV-304 study data further substantiate the role of enfortumab vedotin plus pembrolizumab in bladder cancer and demonstrate its potential to offer patients with muscle-invasive bladder cancer more time with their loved ones. We are delighted with these new data and remain committed to investigating therapies for challenging and hard-to-treat cancers, to bring renewed hope to patients.”

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Related Topics and Keywords

bladder cancer, Cisplatin, cisplatin-Eligible Muscle-Invasive Bladder Cancer, KEYTRUDA, padcev