<div id="readability-page-1"><div><p>Astellas Pharma Inc. and Pfizer Inc. announced positive topline results from an interim analysis of the Phase 3 EV-304 clinical trial (also known as KEYNOTE-B15) for PADCEV? (enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with Keytruda® (pembrolizumab), a PD-1 inhibitor. This pivotal study is evaluating the combination as neoadjuvant and adjuvant treatment (before and after surgery) versus standard of care neoadjuvant chemotherapy (gemcitabine and cisplatin) in patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy.</p><p>The trial met its primary endpoint, demonstrating clinically meaningful and statistically significant improvements in event-free survival (EFS), and overall survival (OS), a key secondary endpoint. An additional secondary endpoint of pathologic complete response (pCR) rate for neoadjuvant PADCEV plus pembrolizumab versus neoadjuvant chemotherapy was also met, and a clinically meaningful and statistically significant improvement was observed. The safety profile for PADCEV plus pembrolizumab was consistent with the known profile of the treatment regimen.</p></div></div>

安斯泰萊制藥(ADR)

輝瑞

<p>安斯泰萊製藥 (ADR) 和輝瑞宣佈第三階段 EV-304 臨牀試驗的中期分析結果積極</p>

Astellas Pharma Inc. and Pfizer Inc. Announces Positive Topline Results from an Interim Analysis of the Phase 3 EV-304 Clinical Trial

- Astellas Pharma 和 Pfizer 公佈了 PADCEV（enfortumab vedotin）的臨牀試驗正面結果。  
- 該研究評估了 PADCEV 與 Keytruda 的聯合治療在肌肉侵襲性膀胱癌患者中的有效性。  
- 結果顯示事件無復發生存率和整體生存率顯著改善，且安全性與已知資料一致。

安斯泰萊製藥 (ADR) 和輝瑞公司宣佈了 3 期 EV-304 臨牀試驗中期分析的積極主要結果