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
The World Cancer Declaration recognises that to make major reductions in premature deaths, innovative education and training opportunities for healthcare workers in all disciplines of cancer control need to improve significantly.
ecancer plays a critical part in improving access to education for medical professionals.
Every day we help doctors, nurses, patients and their advocates to further their knowledge and improve the quality of care. Please make a donation to support our ongoing work.
Thank you for your support.