AstraZeneca(US:AZN)2025-03-31 11:11Imfinzi Approval and Usage - Imfinzi has been approved in the US as the first and only perioperative immunotherapy for muscle-invasive bladder cancer (MIBC), showing a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death compared to neoadjuvant chemotherapy alone[4]. - The perioperative treatment with Imfinzi has been added to the NCCN Clinical Practical Guidelines as a Category 1 Recommended regimen for MIBC[9]. - AstraZeneca is pursuing regulatory applications for Imfinzi in the EU, Japan, and several other countries based on the NIAGARA results[9]. - Since its first approval in May 2017, over 374,000 patients have been treated with Imfinzi across various cancer types[18]. Clinical Trial Results - The NIAGARA Phase III trial demonstrated that over 80% of patients treated with Imfinzi were alive at two years, with an estimated 82.2% overall survival rate compared to 75.2% in the comparator arm[7]. - The Imfinzi-based regimen showed a 32% reduction in the risk of disease progression, with an event-free survival (EFS) hazard ratio of 0.68[6]. - The median event-free survival for the Imfinzi arm was not yet reached, while it was 46.1 months for the comparator arm[6]. Patient Treatment and Safety - In 2024, over 20,000 patients in the US were treated for MIBC, highlighting the significant need for improved treatment options[6]. - Imfinzi was well tolerated, with no new safety signals observed, and immune-mediated adverse events were manageable and mostly low-grade[8]. AstraZeneca's Vision - AstraZeneca aims to redefine cancer care through innovative immunotherapy strategies and extensive clinical programs targeting multiple cancer types[21].