Global Finance News
28 Feb 2026, 13:51
Pfizer Inc. and Astellas Pharma Inc. said their Phase 3 EV-304 (KEYNOTE-B15) trial showed that PADCEV (enfortumab vedotin) plus Keytruda (pembrolizumab) significantly improved outcomes in cisplatin-eligible muscle-invasive bladder cancer (MIBC) patients when used before and after surgery.
The combination reduced the risk of recurrence, progression or death by 47% versus standard neoadjuvant gemcitabine and cisplatin (HR 0.53; p<.0001), with 79.4% of patients event-free at two years compared with 66.2% under standard care. Overall survival improved by 35% (HR 0.65; p=.0029), while 55.8% of patients achieved a pathological complete response at surgery, versus 32.5% in the chemotherapy arm.
Results were presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco. The companies said the platinum-free regimen could establish a new standard of care if approved. PADCEV plus pembrolizumab is already approved in the U.S. for perioperative treatment in cisplatin-ineligible MIBC patients.
Source: Business Wire
The combination reduced the risk of recurrence, progression or death by 47% versus standard neoadjuvant gemcitabine and cisplatin (HR 0.53; p<.0001), with 79.4% of patients event-free at two years compared with 66.2% under standard care. Overall survival improved by 35% (HR 0.65; p=.0029), while 55.8% of patients achieved a pathological complete response at surgery, versus 32.5% in the chemotherapy arm.
Results were presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco. The companies said the platinum-free regimen could establish a new standard of care if approved. PADCEV plus pembrolizumab is already approved in the U.S. for perioperative treatment in cisplatin-ineligible MIBC patients.
Source: Business Wire