Astellas Pharma Inc has announced that the Phase 3 EV‑304 clinical trial of Padcev (enfortumab vedotin) combined with Keytruda (pembrolizumab) has produced positive topline results from an interim analysis.
The EV‑304 study, also known as KEYNOTE‑B15, is evaluating the Padcev‑Keytruda combination given before and after surgery against the current standard neoadjuvant chemotherapy regimen of gemcitabine and cisplatin in patients with muscle‑invasive bladder cancer (MIBC) who are eligible for cisplatin‑based therapy.
The trial met its primary endpoint of event‑free survival (EFS), showing clinically meaningful and statistically significant improvement over standard chemotherapy. The combination also achieved a key secondary endpoint by demonstrating an overall survival (OS) benefit, and the pathologic complete response (pCR) rate as an additional secondary endpoint showed a statistically significant and clinically meaningful improvement with Padcev plus Keytruda.
The safety profile of the combination was consistent with known data for these drugs. The EV‑304 results will be presented at an upcoming medical meeting and discussed with global health authorities for potential regulatory filings. Padcev is a Nectin‑4 directed antibody‑drug conjugate and Keytruda is a PD‑1 inhibitor; the combination is already approved for treatment of locally advanced or metastatic urothelial cancer in multiple regions, and Padcev is also approved as a single agent in other bladder cancer settings.
The ongoing trial involves randomizing patients to receive either Padcev plus Keytruda before and after surgery or standard neoadjuvant chemotherapy, followed by curative‑intent cystectomy, with event‑free survival defined by disease progression preventing surgery, incomplete surgery, recurrence or death.
