Pfizer and Astellas Cancer Drug Combo Shows Survival Gains in Muscle-Invasive Bladder Cancer

NEWS - The PADCEV (enfortumab vedotin) and Keytruda (pembrolizumab) drug combination developed by Pfizer and Astellas has shown significant survival benefits for patients with muscle-invasive bladder cancer, irrespective of their eligibility for platinum-based chemotherapy.

Topline results from an interim analysis of the Phase 3 EV-304 clinical trial met its primary endpoint, demonstrating statistically significant improvements in event-free survival (EFS) and overall survival (OS) compared to the standard of care.

The study evaluated the combination therapy as neoadjuvant and adjuvant treatment (before and after surgery) against platinum-based chemotherapy (gemcitabine and cisplatin) in patients eligible for cisplatin-based treatment. The combination also achieved a clinically meaningful pathological complete response (pCR) rate in this patient group.

"The EV-303 and EV-304 results, together, highlight the potential of perioperative enfortumab vedotin plus pembrolizumab to 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," said Dr. Christopher Hoimes, Director of the Bladder Cancer Program at Duke Cancer Institute.

Bladder cancer is the ninth most common cancer globally, with muscle-invasive bladder cancer accounting for approximately 30% of cases. While platinum-based chemotherapy is the standard treatment for eligible patients, half of them experience disease recurrence after surgery. The PADCEV-pembrolizumab combination is not currently approved for neoadjuvant and adjuvant treatment in cisplatin-eligible MIBC patients. The results will be presented at an upcoming medical meeting and discussed with global health authorities for potential regulatory filings.