AstraZeneca's Imfinzi Perioperative Regimen: A New Hope for Bladder Cancer Patients

AstraZeneca's Imfinzi (durvalumab) has demonstrated promising results in a Phase III trial for muscle-invasive bladder cancer (MIBC) patients, showing improved survival outcomes when used in combination with neoadjuvant chemotherapy. The NIAGARA trial, presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium, revealed that the Imfinzi perioperative regimen reduced the risk of distant metastases and death from bladder cancer versus neoadjuvant chemotherapy alone.



The Imfinzi perioperative regimen involves administering four cycles of Imfinzi in combination with neoadjuvant chemotherapy before radical cystectomy (surgery to remove the bladder) followed by eight cycles of Imfinzi monotherapy. This approach has shown statistically significant and clinically meaningful improvements in event-free survival (EFS) and overall survival (OS) compared to neoadjuvant chemotherapy alone. In patients who achieved a pathologic complete response (pCR), the regimen reduced the risk of disease progression, recurrence, not undergoing surgery, or death by 42%, and in those who did not achieve pCR, the risk was reduced by 23%. The risk of death was reduced by 28% in patients who achieved pCR and by 16% in those who did not.



The Imfinzi perioperative regimen also improved metastasis-free survival (MFS) and disease-specific survival (DSS) in the intent-to-treat (ITT) population. This regimen reduced the risk of developing distant metastases or death by 33% and the risk of death specifically due to bladder cancer by 31% versus the comparator arm. These improvements in MFS and DSS contribute to the overall reduction in the risk of distant metastases and death from bladder cancer.

Matthew ND. Galsky, Lillian and Howard Stratton Professor of Medicine, Director of Genitourinary Medical Oncology, The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, New York, and NIAGARA Investigator and Steering Committee member, commented on the results: "These NIAGARA data confirm the compelling efficacy of the durvalumab perioperative regimen in muscle-invasive bladder cancer, and importantly, show this regimen improved outcomes regardless of whether patients achieved a pathologic complete response. This insight, together with the data showing the durvalumab perioperative regimen extended the time patients live before distant metastases develop, is favorable news for patients with muscle-invasive bladder cancer who are in need of better treatment options."

Cristian Massacesi, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca, added: "NIAGARA was the first Phase III trial of a perioperative immunotherapy regimen in muscle-invasive bladder cancer to show statistically significant and clinically meaningful improvements in event-free and overall survival. The 33 percent reduction in the risk of distant metastases, which are associated with a poorer prognosis, further reinforces the potential of perioperative Imfinzi to become a new standard of care in this setting."

The addition of Imfinzi to neoadjuvant chemotherapy has been generally well-tolerated, with no new safety signals observed in the neoadjuvant and adjuvant settings. The safety profile of Imfinzi and neoadjuvant chemotherapy was consistent with the known profile of the individual medicines, and the addition of Imfinzi did not compromise patients' ability to complete surgery compared to neoadjuvant chemotherapy alone. Immune-mediated adverse events (imAEs) were consistent with the known profile of Imfinzi, manageable, and mostly low-grade.

Perioperative Imfinzi in combination with neoadjuvant chemotherapy was granted Priority Review in the US in December 2024 for the treatment of patients with MIBC. Regulatory applications are also currently under review in the European Union (EU), Japan, and several other countries based on the NIAGARA trial.

In conclusion, AstraZeneca's Imfinzi perioperative regimen has shown promising results in improving survival outcomes for MIBC patients. With its potential to become a new standard of care, this regimen offers hope for patients and their families, as well as for healthcare providers and researchers in the field of bladder cancer treatment. As the regulatory approval process continues, the impact of this innovative approach on the market and the broader healthcare landscape remains to be seen.