Perioperative Imfinzi plus neoadjuvant EV showed statistically significant EFS/OS improvements in MIBC in Ph 3 VOLGA trial
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “This interim analysis from the VOLGA trial highlights the benefit of perioperative Imfinzi with neoadjuvant enfortumab vedotin compared to surgery, a novel regimen that optimises treatment options for patients. Together with NIAGARA and POTOMAC, VOLGA is our third positive readout in bladder cancer, setting a strong foundation for Imfinzi as the immunotherapy backbone in this early-stage, curative-intent setting.”
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The sNDA is based on results from the Phase 3 EV-304 clinical trial (also known as KEYNOTE-B15). In EV-304, neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab was compared with standard-of-care neoadjuvant gemcitabine and cisplatin chemotherapy in MIBC patients eligible for cisplatin-containing chemotherapy. In the Event-Free Survival (EFS) analysis, enfortumab vedotin
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