New data from the NIAGARA Phase III trial reveals that a perioperative regimen including durvalumab significantly improves outcomes for patients with muscle-invasive bladder cancer (MIBC). The study demonstrated a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death compared to neoadjuvant chemotherapy alone.
The NIAGARA trial evaluated the efficacy and safety of adding durvalumab, an anti-PD-L1 immune checkpoint inhibitor, to neoadjuvant chemotherapy followed by adjuvant durvalumab monotherapy, versus neoadjuvant chemotherapy alone. The results indicate a clinically meaningful benefit in both recurrence-free survival (RFS) and overall survival (OS).
Key Findings from the NIAGARA Trial
The study, involving patients with resectable MIBC, showed that the addition of durvalumab to neoadjuvant chemotherapy did not compromise patients’ ability to complete surgery. The safety profile of the combination was consistent with that of durvalumab and chemotherapy alone. Grade 3 and 4 adverse events occurred in 69% of patients treated with durvalumab and 68% of patients treated with neoadjuvant chemotherapy.
“The results from the NIAGARA trial mark a significant step forward in the treatment of muscle-invasive bladder cancer,” said lead investigator Dr. [Name], [Title], [Institution]. “The observed reduction in both recurrence and mortality underscores the potential of durvalumab to transform the perioperative management of this aggressive disease.”
Current Treatment Landscape and Unmet Needs
MIBC is an aggressive form of bladder cancer that has a high risk of recurrence and progression, even after radical cystectomy. Neoadjuvant chemotherapy is a standard of care, but its benefits are limited, and many patients still experience disease recurrence. The addition of immune checkpoint inhibitors like durvalumab to the perioperative setting represents a promising strategy to improve long-term outcomes.
AstraZeneca is also investigating durvalumab across various stages of bladder cancer, including non-muscle invasive disease (in the POTOMAC trial), cisplatin-ineligible MIBC (VOLGA), and locally advanced or metastatic disease (NILE).
About Durvalumab
Durvalumab is a human monoclonal antibody that binds to the PD-L1 protein and blocks its interaction with PD-1 and CD80, unleashing the anti-tumor immune response. It is approved for various cancer types, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and biliary tract cancers (BTC).
