UK-based pharmaceutical company AstraZeneca has reported positive results from the Phase III NIAGARA trial of Imfinzi alongside neoadjuvant chemotherapy.
The combination therapy was found to improve survival rates among muscle-invasive bladder cancer (MIBC) patients in the study.
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The open-label, randomised, multicentre trial assessed perioperative Imfinzi as a treatment in MIBC patients with or without a pathologic complete response (pCR), before and after radical cystectomy.
It has enrolled 1,063 patients and is being carried out at 192 centres across 22 countries.
The NIAGARA trial’s post-hoc exploratory subgroup analysis showed that the perioperative regimen enhanced event-free survival (EFS) and overall survival (OS) compared to neoadjuvant chemotherapy plus radical cystectomy alone.
The study’s dual primary endpoints were EFS and pCR, with its key secondary endpoints including OS and safety.
According to the findings, the Imfinzi regimen not only improved EFS and OS in patients with and without pCR, but also showed benefits in metastasis-free survival and disease-specific survival.
The Imfinzi regimen reduced the risk of disease progression, recurrence or death in subjects achieving pCR by 42% and caused a 23% reduction in patients who did not achieve pCR.
AstraZeneca Oncology chief development officer and chief medical officer Cristian Massacesi said: “NIAGARA was the first Phase III trial of a perioperative immunotherapy regimen in muscle-invasive bladder cancer to show statistically significant and clinically meaningful improvements in event-free and overall survival.
“The 33% reduction in the risk of distant metastases, which are associated with a poorer prognosis, further reinforces the potential of perioperative Imfinzi to become a new standard of care in this setting.”
In December last year, the US Food and Drug Administration (FDA) granted priority review for Imfinzi in combination with neoadjuvant chemotherapy for MIBC.
Regulatory reviews for the treatment regimen are currently underway in the EU, Japan and other countries.
