By Fineline Cube 
The US Food and Drug Administration (FDA) has approved AstraZeneca’s (NASDAQ: AZN) PD-L1 inhibitor Imfinzi (durvalumab) for use in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after radical cystectomy, for adults with muscle-invasive bladder cancer (MIBC).
Clinical Trial Results
The approval is supported by results from the Phase III NIAGARA trial (NCT03732677), which enrolled 1,063 patients eligible for radical cystectomy who had not received prior systemic therapy for bladder cancer. The trial demonstrated significant improvements in event-free survival (EFS) and overall survival (OS). Patients receiving neoadjuvant durvalumab with chemotherapy followed by adjuvant durvalumab showed a median EFS that was not reached versus 46.1 months for those receiving neoadjuvant chemotherapy followed by surgery alone (HR 0.68). The median OS was also not reached, with a hazard ratio of 0.75, indicating a favorable survival benefit.
Safety Profile
The safety profile of the regimen was consistent with previous findings, supporting the use of Imfinzi in this treatment setting.-Fineline Info & Tech