AstraZeneca’s Imfinzi (durvalumab) has been approved in the European Union (EU) for the treatment of adult patients with resectable muscle-invasive bladder cancer (MIBC) in combination with gemcitabine and cisplatin as neoadjuvant treatment. 

According to the decision, this treatment should be followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy (surgery to remove the bladder). 

The approval is based on the NIAGARA Phase III trial results, which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death for the Imfinzi regimen vs. neoadjuvant chemotherapy alone. 

An estimated 67.8% of patients treated with the regimen were event free at two years compared to 59.8% in the comparator arm. An estimated 82.2% of Imfinzi patients were alive at two years compared to 75.2%. 

A new survival benchmark in bladder cancer

Dr Michiel Van der Heijden, Medical Oncologist and Group Leader at the Netherlands Cancer Institute, and investigator in the NIAGARA trial, said: “The durvalumab-based perioperative regimen is an important new treatment option for patients in Europe with muscle-invasive bladder cancer, as currently nearly half experience disease recurrence despite treatment with neoadjuvant chemotherapy and surgery to remove the bladder. The NIAGARA results showed how this regimen reduced the risk of recurrence by nearly a third and significantly extended survival, underscoring its potential to transform clinical practice in this curative-intent setting.” 

The European Society for Medical Oncology (ESMO) has published its assessment of the NIAGARA regimen against the Magnitude of Clinical Benefit Scale (MCBS), awarding it the highest possible grade of “A” in the curative setting. 

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, added: “Imfinzi is poised to transform the standard of care for muscle-invasive bladder cancer in Europe as the first and only perioperative immunotherapy for these patients. In the NIAGARA Phase III trial, more than 80% of patients were still alive two years after treatment with the Imfinzi regimen, setting a new survival benchmark for a disease that has seen few treatment advances in decades.” 

Imfinzi is approved in the US and other countries in this setting based on the NIAGARA results. 

Diana Turner, Senior Digital Content Editor, DDW