<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>

安斯泰莱制药(ADR)

辉瑞

<p>安斯泰莱制药 (ADR) 和辉瑞宣布第三阶段 EV-304 临床试验的中期分析结果积极</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 公布了 PADCEV（enfortumab vedotin）的临床试验正面结果。  
- 该研究评估了 PADCEV 与 Keytruda 的联合治疗在肌肉侵袭性膀胱癌患者中的有效性。  
- 结果显示事件无复发生存率和整体生存率显著改善，且安全性与已知资料一致。

安斯泰莱制药 (ADR) 和辉瑞公司宣布了 3 期 EV-304 临床试验中期分析的积极主要结果