AstraZeneca’s Imfinzi Reduces Risk Of Progression And Death In Bladder Cancer, CHMP Backs Approval Based On NIAGARA Trial

AstraZeneca’s Imfinzi (durvalumab) has received a positive recommendation from the European Medicines Agency’s CHMP for approval in the European Union (EU) to treat resectable muscle-invasive bladder cancer (MIBC). The regimen includes Imfinzi combined with gemcitabine and cisplatin as neoadjuvant therapy, followed by Imfinzi monotherapy after radical cystectomy. This recommendation is based on Phase III NIAGARA trial data, previously presented at ESMO 2024 and published in The New England Journal of Medicine.

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, commented,  “The Imfinzi-based perioperative regimen in the NIAGARA Phase III trial enabled survival of more than 80 per cent of patients at two years after treatment. This supports our strategy of moving our innovative medicines into the earlier stages of disease where the opportunity for treatment with curative intent is greatest. If approved, this novel approach will become a much-needed new treatment option for patients in Europe and could become the new standard of care in this setting.”

The trial showed that the Imfinzi-based perioperative regimen reduced the risk of disease progression, recurrence, or death by 32% versus standard neoadjuvant chemotherapy and surgery (HR 0.68; p<0.0001). At two years, 67.8% of patients were event-free compared to 59.8% in the control group. Additionally, overall survival improved, with a 25% reduced risk of death (HR 0.75; p=0.0106), and 82.2% of patients treated with Imfinzi were alive at two years compared to 75.2% for the comparator.

Dr Michiel Van der Heijden, medical oncologist and Group Leader at the Netherlands Cancer Institute, and investigator in the NIAGARA trial, stated, “Approximately half of patients with muscle-invasive bladder cancer will experience disease recurrence despite curative-intent treatment with neoadjuvant chemotherapy and surgery to remove the bladder. This recommendation for the durvalumab-based perioperative regimen brings us closer to providing an important new treatment option that has demonstrated a significant survival benefit, with the potential to transform the treatment approach for patients across Europe.”

Bladder cancer becomes “muscle-invasive” when it invades the bladder wall muscle but hasn't metastasized. Though considered treatable with curative intent, recurrence remains a major issue. Imfinzi was generally well tolerated, with no new safety signals and no adverse effect on surgery outcomes. The drug is already approved for this setting in the US, with regulatory reviews ongoing in Japan and other countries.