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PADCEV™ Plus KEYTRUDA™, Given Before and After Surgery, Cuts the Risk of Recurrence, Progression or Death by 60% and the Risk of Death by 50% for Certain Patients with Bladder Cancer
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) today announced positive results from the pivotal Phase 3 EV-303 clinical trial (also known as KEYNOTE-905) for PADCEV™ (enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with KEYTRUDA™ (pembrolizumab), a PD-1 inhibitor. The study evaluated the combination in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or declined cisplatin-based
About this update from Pfizer, Inc.
[{"type":"list","items":[{"val":[{"type":"text","content":"First and only combination regimen to improve survival when used before and after surgical cystectomy in cisplatin-ineligible patients with muscle-invasive bladder cancer","length":170,"tagName":"p"}]},{"val":[{"type":"text","content":"Unprecedented survival results from pivotal Phase 3 EV-303 trial show potential for PADCEV plus KEYTRUDA to redefine standard of care","length":133,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":303,"olType":false},{"type":"text","content":"TOKYO and NEW YORK, Oct. 18, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) today announced positive results from the pivotal Phase 3 EV-303 clinical trial (also known as KEYNOTE-905) for PADCEV™ (enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with KEYTRUDA™ (pembrolizumab), a PD-1 inhibitor. The study evaluated the combination in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or declined cisplatin-based chemotherapy. PADCEV plus KEYTRUDA significantly improved event-free survival (EFS) and overall survival (OS) when used as a neoadjuvant and adjuvant treatment (before and after surgery) versus the current standard of care—surgery alone. Results from the EV-303 trial will be presented today in a Presidential Symposium (Abstract #LBA2) at the 2025 European Society of Medical Oncology (ESMO) Congress in Berlin, Germany.","length":992,"tagName":"p"},{"type":"image","alt":"Pfizer | Astellas","displaySize":"","headline":null,"caption":"Pfizer | Astellas","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":97,"url":"https://media.zenfs.com/en/prnewswire.com/538cc2b9d8ecb50adbc09b44a523e1dc"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/qQ.bUhYNakdHBvmBLOE3eA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTE3MTtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/538cc2b9d8ecb50adbc09b44a523e1dc","width":400,"height":97}},"href":"https://mma.prnewswire.com/media/2799219/Pfizer_Astellas_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"At the first interim efficacy analysis, results from the primary endpoint of EFS showed a 60% reduction in the risk of tumor recurrence, progression or death for patients treated w...