Phase 3 NIAGARA Trial of Durvalumab/Chemo Shows Enhanced Survival in MIBC

womans bladder cancer: © vitanovski - stock.adobe.com

The combination of durvalumab (Imfinzi) with chemotherapy elicited a statistically significant and clinically meaningful improvement in event-free survival (EFS) and overall survival (OS), the primary and a key secondary end point of the phase 3 NIAGARA trial (NCT03732677), vs neoadjuvant chemotherapy when used for the treatment of patients with muscle-invasive bladder cancer (MIBC).¹

Positive high-level results from the phase 3 NIAGARA trial come from patients given the combination prior to cystectomy followed by durvalumab as adjuvant monotherapy. For safety, treatment with durvalumab was generally well-tolerated with no new safety signals seen in either the neoadjuvant or adjuvant setting. The safety profile ofdurvalumab and neoadjuvant chemotherapy was similar to what has been previously observed with each agent individually.

Moreover, safety findings showed that adding durvalumab to chemotherapy did not lead to an increased discontinuation rate due to adverse events. The addition also did not affect the patients' ability to complete surgery vs treatment with neoadjuvant chemotherapy alone.

“Nearly half of patients with muscle-invasive bladder cancer who receive standard of care still experience disease recurrence or progression. These NIAGARA data show for the first time that adding durvalumab to chemotherapy before surgery followed by durvalumab extends patients’ lives,” Thomas Powles, MD, professor, director of Barts Cancer Centre, London, UK, and investigator on the trial, said in a press release.

These data are expected to be presented at an upcoming medical meeting and shared with global regulatory authorities.

About the NIAGARA Study

The randomized, open-label, multicenter, global, phase 3 NIAGARA trial is assessing the efficacy and safety of treatment with durvalumab in patients with MIBC before and after radical cystectomy.

A total of 1063 patients were randomized to receive the combination of durvalumab and chemotherapy or chemotherapy alone before cystectomy followed by durvalumab or no additional treatment after surgery.

Enrollment in the study was open to patients with resectable MIBC with clinical stage T2 to T4aN0/1M0 with transitional and mixed transitional cell histology who were planning to undergo a radical cystectomy and who have not received prior systemic chemotherapy or immunotherapy for the treatment of their MIBC.² An ECOG performance status of 0 or 1 and a life expectancy of at least 12 weeks at randomization were also required.

In addition to EFS, the dual primary end point of the study was pathologic complete response. Key secondary end points of the study consisted of OS and safety.

The trial is being conducted at 192 centers across 22 countries and regions. These include North America, South America, Europe, Australia, and Asia. The estimated study completion date is June 30, 2026.¹

REFERENCES:
1. Imfinzi demonstrated statistically significant and clinically meaningful improvement in event-free survival and overall survival for muscle-invasive bladder cancer in NIAGARA phase III trial. News release. AstraZeneca. June 25, 2024. Accessed June 25, 2024. https://tinyurl.com/55vd329v

2. Durvalumab+ gemcitabine/​cisplatin (neoadjuvant treatment) and durvalumab (adjuvant treatment) in patients with MIBC (NIAGARA). ClinicalTrials.gov. Updated March 18, 2024. Accessed June 25, 2024. https://clinicaltrials.gov/study/NCT03732677