AstraZeneca has received the US Food and Drug Administration (FDA) approval for Imfinzi (durvalumab), combined with gemcitabine and cisplatin as a neoadjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC).
The approval, which follows a Priority Review from the FDA, is based on the NIAGARA Phase 3 trial results, highlighting Imfinzi’s efficacy in this setting.
The NIAGARA trial is a randomised, open-label, multi-centre global study evaluating perioperative Imfinzi for MIBC patients before and after radical cystectomy.
Involving 1,063 patients, the trial was conducted across 192 centres in 22 countries, including Australia, Europe, North America, and South America.
AstraZeneca oncology haematology business unit executive vice president Dave Fredrickson said: “Today’s approval for Imfinzi represents a paradigm shift, bringing the first perioperative immunotherapy to patients in the US with muscle-invasive bladder cancer and addressing a significant need for better treatment options.
“The NIAGARA trial showed more than 80 per cent of patients were still alive at two years, underscoring the potential of this innovative perioperative regimen to become a new standard of care in this setting.”
In the study, patients received four cycles of Imfinzi with chemotherapy before surgery, followed by eight cycles of Imfinzi alone.
The interim analysis showed a 32% reduction in the risk of disease progression, recurrence, or death with the Imfinzi regimen compared to chemotherapy alone.
The trial also showed a 25% reduction in the risk of death with the Imfinzi regimen, with a hazard ratio for overall survival (OS) of 0.75.
The Imfinzi group showed a survival rate of 82.2% at two years, compared to 75.2% for the comparator, and was well tolerated with no new safety signals.
Furthermore, Imfinzi is approved in Brazil for the same indication, with regulatory reviews ongoing in the EU, Japan, and other countries.
NIAGARA investigator and steering committee member Matthew Galsky said: “This approval for the durvalumab-based perioperative regimen is a major breakthrough for people with muscle-invasive bladder cancer, nearly half of whom see their cancer return despite chemotherapy and surgery with curative-intent.
“This durvalumab regimen significantly extended patients’ lives in the NIAGARA trial and has the potential to transform care.”
Bladder Cancer Advocacy Network CEO Meri-Margaret Deoudes said: “The approval of the durvalumab perioperative regimen is welcome news, transforming how clinicians will tackle this disease in future and offering new hope to patients and their loved ones.”
