Positive results from the NIAGARA phase III trial showed presented at ESMO 2024 showed 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).

Patients were treated with durvalumab in combination with neoadjuvant chemotherapy before radical cystectomy followed by durvalumab as adjuvant monotherapy.

In a planned interim analysis, patients treated with the durvalumab 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 durvalumab arm versus 46.1 months for the comparator arm.

An estimated 67.8% of patients treated with the durvalumab regimen were event free at two years compared to 59.8% in the comparator arm.

Results from the key secondary endpoint of OS showed the durvalumab perioperative regimen reduced the risk of death by 25% versus neoadjuvant chemotherapy with radical cystectomy (based on OS HR of 0.75; 95% CI 0.59-0.93; p=0.0106). Median survival was not yet reached for either arm. An estimated 82.2% of patients treated with the durvalumab regimen were alive at two years compared to 75.2% in the comparator arm.

Professor Thomas Powles, MD, Director of Barts Cancer Centre (QMUL), London, UK, and principal investigator in the NIAGARA trial, said: “Neoadjuvant chemotherapy with bladder removal has been the mainstay of treatment for patients with muscle-invasive bladder cancer for nearly twenty years; however, half of patients still go to suffer a devastating recurrence. Adding durvalumab before and after surgery significantly reduced the chance of recurrence and extended survival, a significant advance with the potential to transform the standard of care for these patients who desperately need better outcomes.”

Source: AstraZeneca