<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>

ALPMY

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

- Astellas Pharma Inc. and Pfizer Inc. reported positive topline results from the interim analysis of the Phase 3 EV-304 clinical trial for PADCEV? (enfortumab vedotin) combined with Keytruda® (pembrolizumab) in patients with muscle-invasive bladder cancer.  
- The trial met its primary endpoint, showing significant improvements in event-free survival and overall survival, and also achieved a notable pathologic complete response rate compared to standard chemotherapy.  
- The safety profile of the combination treatment was consistent with existing data on the regimen.