Pfizer and Astellas’ Padcev-Keytruda Combo Extends Survival in Bladder Cancer

Pfizer and Astellas, alongside MSD, announced that Padcev (enfortumab vedotin) plus Keytruda (pembrolizumab) achieved positive results in the Phase III EV-303/KEYNOTE-905 trial (NCT03924895) for muscle-invasive bladder cancer (MIBC). The perioperative regimen significantly improved event-free survival (EFS) and overall survival (OS) compared to surgery alone, while also meeting the pathologic complete response (pCR) endpoint.

The combination is being assessed as both neoadjuvant and adjuvant therapy for cisplatin-ineligible MIBC patients, who represent nearly half of cases and currently have limited treatment options beyond surgery. The companies emphasized that this marks the first regimen to demonstrate survival benefits in this setting, potentially redefining the standard of care.

Pfizer, which gained Padcev through its $43bn Seagen acquisition, is aiming to expand its use beyond its existing approvals in urothelial cancer. Analysts forecast Padcev sales to rise from $2.6bn in 2025 to $6.3bn in 2031, driven by additional oncology indications.

17-08-2025