ESMO 2024: Imfinzi NIAGARA Phase III trial success in bladder cancer

Positive results from the NIAGARA Phase III trial showed that UK pharma major AstraZeneca’s (LSE: AZN) Imfinzi (durvalumab) in combination with chemotherapy demonstrated a statistically-significant and clinically-meaningful improvement in the primary endpoint of event-free survival (EFS) and the key secondary endpoint of overall survival (OS) versus neoadjuvant chemotherapy for patients with muscle-invasive bladder cancer (MIBC).

The data, which were presented at the Presidential Symposium at the 2024 European Society for Medical Oncology (ESMO), noted that

patients treated with the Imfinzi perioperative regimen showed a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus the comparator arm (based on EFS hazard ratio [HR] of 0.68; 95% confidence interval [CI] 0.56-0.82; p<0.0001). Estimated median EFS was not yet reached for the Imfinzi arm versus 46.1 months for the comparator arm. An estimated 67.8% of patients treated with the Imfinzi regimen were event free at two years compared to 59.8% in the comparator arm.