By Fineline Cube 
UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Imfinzi (durvalumab) as a perioperative treatment for bladder cancer. This decision is based on the results from the pivotal NIAGARA Phase III trial.
Clinical Trial Results
The NIAGARA trial demonstrated that the Imfinzi regimen reduced the risk of bladder cancer recurrence by 32% and the risk of death by 25%, compared to neoadjuvant chemotherapy alone. This significant reduction highlights the potential of Imfinzi to improve outcomes for patients with muscle-invasive bladder cancer (MIBC).
NIAGARA Trial Details
NIAGARA is a randomized, open-label, multicenter, global Phase III trial designed to assess Imfinzi as a perioperative therapy for patients with MIBC before and after radical cystectomy. The trial enrolled 1,063 patients across 192 centers in 22 countries. Patients were randomized to receive either four cycles of Imfinzi plus neoadjuvant chemotherapy (gemcitabine/cisplatin) before surgery, followed by eight cycles of Imfinzi monotherapy after surgery, or neoadjuvant chemotherapy alone. The dual primary endpoints are event-free survival (EFS) and pathologic complete response at the time of cystectomy. Key secondary endpoints include overall survival (OS) and safety.-Fineline Info & Tech