AstraZeneca’s perioperative Imfinzi ‘significantly extends survival’ in type of bladder cancer
AstraZeneca’s perioperative Imfinzi ‘significantly extends survival’ in type of bladder cancer
A perioperative regimen of PD-L1 blocker Imfinzi yielded “clinically meaningful” survival benefits for patients with muscle-invasive bladder cancer, AstraZeneca announced Sunday.
The readout comes from the Phase III NIAGARA study, which tested an investigational perioperative regimen of Imfinzi (durvalumab) with chemotherapy before cystectomy, followed by Imfinzi after surgery. As a comparator, AstraZeneca used Imfinzi before surgery followed by no further treatment after the operation. NIAGARA’s primary endpoint is event-free survival (EFS) and a key secondary endpoint is overall survival (OS).
Results, which were presented at the 2024 European Society for Medical Oncology Congress (ESMO 2024), showed that the perioperative schedule resulted in a 32% drop in the risk of disease progression, recurrence, not undergoing surgery or death. This effect was statistically significant, with a p-value less than 0.0001. At the time of the analysis, estimated EFS was not yet reached in patients on the Imfinzi regimen versus 46.1 months in comparators.
At two years, 67.8% of Imfinzi-treated patients were event-free, as opposed to 59.8% of patients in the comparator arm. OS was also better after treatment with the Imfinzi regimen, which significantly reduced the risk of death by 25% versus radical cystectomy with neoadjuvant chemotherapy.
NIAGARA found the perioperative Imfinzi regimen to be well-tolerated with no new safety signals. Adding Imfinzi to neoadjuvant chemotherapy did not impair patients’ ability to complete surgery versus neoadjuvant treatment alone, according to AstraZeneca’s news release.
Susan Galbraith, AstraZeneca’s executive vice president of Oncology R&D, said in a statement said that the NIAGARA data showed perioperative Imfinzi can elicit “compelling improvements” in muscle-invasive bladder cancer.
“This is the first immunotherapy regimen to significantly extend overall survival in muscle-invasive bladder cancer, and it further validates our strategy to move cancer treatment as early as possible to maximize benefit for patients,” Galbraith added.
