Global pharma giant Pfizer and Astellas Pharma have unveiled compelling results in their muscle-invasive bladder cancer trial.

 

As per the companies, phase 3 data from the EV-304 trial showed that the combination of PADCEV (enfortumab vedotin) and Keytruda (pembrolizumab) dramatically improves outcomes for patients with muscle-invasive bladder cancer (MIBC) eligible for cisplatin-based chemotherapy.

 

The perioperative regimen—administered before and after surgery—reduced the risk of tumor recurrence, progression, or death by 47% compared to standard treatment. After two years, an estimated 79.4% of patients treated with the combination were event-free, versus 66.2% on standard chemotherapy.

 

Christopher Hoimes, Director of the Bladder Cancer Program at Duke Cancer Institute and EV-304 Principal Investigator, emphasized the significance: "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."

 

Key secondary outcomes were also impressive. Overall survival improved, with a 35% reduced risk of death for patients on the combination therapy.

 

Jeff Legos, Chief Oncology Officer at Pfizer, said: “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, Head of Oncology Development at Astellas, added: "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, with a goal of bringing renewed hope to patients.”