Imfinzi Approved in EU as First Perioperative Immunotherapy for Muscle-Invasive Bladder Cancer
Friday, July 04, 2025
AstraZeneca’s Imfinzi (durvalumab) has been approved by the European Commission for use in adult patients with resectable muscle-invasive bladder cancer (MIBC). The treatment involves a combination of Imfinzi with gemcitabine and cisplatin as neoadjuvant therapy, followed by Imfinzi alone as adjuvant therapy after bladder removal surgery (radical cystectomy).
The approval is based on data from the NIAGARA Phase III clinical trial, which showed that the Imfinzi-based treatment regimen significantly improved outcomes compared to standard care. In the interim analysis, this approach reduced the risk of disease progression, recurrence, failure to undergo surgery, or death by 32% compared to chemotherapy alone. At two years, 67.8% of patients receiving the Imfinzi regimen were event-free, compared with 59.8% in the control group.
In terms of overall survival, the regimen also lowered the risk of death by 25%. At the two-year mark, 82.2% of patients treated with the Imfinzi combination were still alive, compared to 75.2% in the comparator arm.
Muscle-invasive bladder cancer is a serious condition affecting more than 35,000 people across the five major European countries in 2024. Although surgery combined with chemotherapy is considered potentially curative, many patients experience a return of the disease after treatment.
The NIAGARA trial results highlight the potential of Imfinzi to improve long-term survival outcomes in this patient group. The treatment was generally well tolerated, with no unexpected safety concerns. The addition of Imfinzi to chemotherapy did not interfere with patients’ ability to undergo surgery, and immune-related side effects were manageable and mostly mild.
The European Society for Medical Oncology (ESMO) has rated the Imfinzi regimen with the highest score of “A” on its Magnitude of Clinical Benefit Scale (MCBS) in the curative setting, recognising its value in clinical practice and decision-making.
Imfinzi is already approved for this indication in the United States and other countries, with regulatory reviews underway in Japan and additional regions. It is also authorised in other curative settings, including non-small cell lung cancer and small cell lung cancer, based on results from the PACIFIC, AEGEAN, and ADRIATIC Phase III trials.
Source: astrazeneca.com
