Imfinzi Receives CHMP Recommendation in the EU as First Perioperative Immunotherapy for Muscle-Invasive Bladder Cancer
Tuesday, May 27, 2025
Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for use in adult patients with resectable muscle-invasive bladder cancer (MIBC). The recommendation covers its use alongside gemcitabine and cisplatin as a neoadjuvant treatment, followed by Imfinzi alone as adjuvant therapy after bladder removal surgery (radical cystectomy).
The decision is based on findings from the Phase III NIAGARA trial, which were presented at the 2024 European Society for Medical Oncology (ESMO) Congress and published in The New England Journal of Medicine.
In an interim analysis, the Imfinzi-based treatment plan showed a 32% reduction in the risk of disease progression, recurrence, missing surgery, or death compared to standard treatment. The hazard ratio for event-free survival (EFS) was 0.68, with a 95% confidence interval of 0.56 to 0.82. The median EFS was not yet reached in the Imfinzi group, while it was 46.1 months in the comparator arm. At the two-year mark, 67.8% of patients receiving the Imfinzi regimen remained event-free, compared to 59.8% in the control group.
Overall survival (OS), a key secondary outcome, showed a 25% reduction in the risk of death with the Imfinzi-based approach. The hazard ratio for OS was 0.75, with a 95% confidence interval of 0.59 to 0.93. Median overall survival had not yet been reached in either group. At two years, 82.2% of patients treated with Imfinzi were still alive, versus 75.2% in the comparator arm.
Muscle-invasive bladder cancer affects over 35,000 people across the five major European countries each year. This stage of cancer is defined by tumour invasion into the bladder muscle wall, without distant metastases. Although current treatment typically includes chemotherapy before surgery (neoadjuvant) followed by bladder removal, many patients still face recurrence and poor outcomes.
Imfinzi was generally well tolerated in the NIAGARA trial, with no new safety concerns reported. The addition of Imfinzi to chemotherapy did not interfere with patients’ ability to undergo surgery. Immune-related side effects were in line with known safety data and were mostly mild and manageable.
The therapy is already approved for use in the United States and other regions based on NIAGARA trial results. Applications are also being reviewed in Japan and several additional countries.
If granted final approval in the EU, Imfinzi would become the first and only perioperative immunotherapy available for muscle-invasive bladder cancer, offering a new treatment option aimed at improving long-term survival in patients.
Source: astrazeneca.com
