Onco-Summaries: Daily Oncology Updates at a Glance

04/07/2025

Imfinzi has been approved by the EC as a perioperative immunotherapy for muscle-invasive bladder cancer (Ref)

• AstraZeneca’s neoadjuvant durvalumab (Imfinzi; anti-PD-L1) in combination with gemcitabine and cisplatin followed by adjuvant durvalumab monotherapy after radical cystectomy for adult patients with resectable muscle-invasive bladder cancer (MIBC) has been approved in the EU

  
  

  • The approval follows the positive CHMP opinion and is based on results from the Phase 3 NIAGARA trial

    
    

    • In a planned interim analysis, the regimen elicited a statistically significant EFS benefit vs neoadjuvant chemotherapy with radical cystectomy alone (HR 0.68; p<0.0001)

      
      

    • median EFS: NR vs 46.1 mos

      
      

    • OS HR 0.75; p=0.0106