AstraZeneca: IMFINZI improved event-free survival, OS across MIBC

Results from a post-hoc exploratory subgroup analysis from the NIAGARA Phase III trial showed AstraZeneca’s (AZN) IMFINZI, administered perioperatively in combination with neoadjuvant chemotherapy, demonstrated improvements in event-free survival and overall survival versus neoadjuvant chemotherapy with radical cystectomy alone in patients with or without a pathologic complete response in muscle-invasive bladder cancer. Patients were treated with four cycles of IMFINZI in combination with neoadjuvant chemotherapy before radical cystectomy followed by eight cycles of IMFINZI monotherapy. These new data were presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium. In NIAGARA, treatment with the IMFINZI perioperative regimen improved EFS and OS versus the comparator arm both in patients who achieved pCR and those who did not. This regimen reduced the risk of disease progression, recurrence, not undergoing surgery, or death by 42% in patients who achieved pCR and by 23% in those who did not; and reduced the risk of death by 28% in patients who achieved pCR and by 16% in those who did not. The IMFINZI perioperative regimen also improved metastasis-free survival and disease-specific survival, two secondary endpoints, versus the comparator arm in the intent-to-treat 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 new data build on findings presented at the European Society for Medical Oncology Congress and published in The New England Journal of Medicine which showed NIAGARA met the primary endpoint of EFS and the key secondary endpoint of OS.