AstraZeneca's IMFINZI (durvalumab) in combination with chemotherapy has demonstrated a statistically significant and clinically meaningful improvement in both event-free survival (EFS) and overall survival (OS) in patients with muscle-invasive bladder cancer, according to results from the NIAGARA Phase III trial. The study compared the IMFINZI perioperative regimen (IMFINZI plus chemotherapy before radical cystectomy, followed by IMFINZI as adjuvant monotherapy) to neoadjuvant chemotherapy alone.
The planned interim analysis revealed a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death in the IMFINZI arm compared to the comparator arm. The estimated median EFS was not yet reached for the IMFINZI arm, while it was 46.1 months for the chemotherapy-only arm. Furthermore, 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.
Overall Survival Benefit
The key secondary endpoint of overall survival also favored the IMFINZI perioperative regimen, with a 25% reduction in the risk of death compared to neoadjuvant chemotherapy with radical cystectomy. Median survival was not yet reached for either arm at the time of the analysis. The two-year survival rate was estimated at 82.2% for patients treated with the IMFINZI regimen, versus 75.2% for those receiving chemotherapy alone.
These findings suggest a significant clinical benefit for patients with muscle-invasive bladder cancer when treated with the IMFINZI-based perioperative regimen. The results could potentially change the standard of care for this patient population.
