By Fineline Cube 
UK-based AstraZeneca (AZ, NASDAQ: AZN) announced that it has received marketing approval in the European Union (EU) for Imfinzi (durvalumab). This approval makes Imfinzi the first and only immunotherapy for the perioperative treatment of resectable muscle-invasive bladder cancer (MIBC) in the region. The regimen involves combining neoadjuvant Imfinzi with gemcitabine and cisplatin before surgery, followed by adjuvant Imfinzi monotherapy post-operation.
Clinical Trial Results
The approval is based on results from the Phase III NIAGARA study. The study demonstrated that the Imfinzi regimen significantly improved event-free survival (EFS) compared to the neoadjuvant chemotherapy group alone, reducing the risk of disease recurrence or death by 32%. The two-year EFS rate was 67.8% for the Imfinzi group, compared to 59.8% in the control group. The overall tolerability was good, with no new safety signals observed.
Mechanism of Action
Imfinzi is a PD-L1-blocking monoclonal antibody that disrupts tumor immune evasion by inhibiting PD-L1 interactions with PD-1/CD80. The drug is already approved for the treatment of non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, and biliary tract cancer. This approval further expands its application into perioperative and combination immunotherapy across various malignancies.-Fineline Info & Tech