AstraZeneca (AZ) has shared positive results from a late-stage study of its Imfinzi (durvalumab) combination in muscle-invasive bladder cancer (MIBC).
The phase 3 NIAGARA trial randomised more than 1,000 MIBC patients to receive Imfinzi plus chemotherapy or chemotherapy alone prior to bladder removal surgery, followed by Imfinzi or no further treatment.
The Imfinzi/chemotherapy combination demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival and the key secondary endpoint of overall survival versus neoadjuvant chemotherapy, AZ said.
It added that Imfinzi was generally well-tolerated and that no new safety concerns were observed in the neoadjuvant or adjuvant setting.
More than 614,000 patients globally are diagnosed with bladder cancer every year and MIBC, named for its growth into the muscle wall of the bladder, accounts for about one in four cases.
Approximately half of patients who undergo bladder removal surgery experience disease recurrence and AZ has outlined that treatment options that prevent disease recurrence after surgery are “critically needed”.
Susan Galbraith, executive vice president, oncology research and development, AZ, said the results from NIAGARA support the company’s strategy to “move immunotherapy to the early stages of cancer treatment”.
“This perioperative regimen with Imfinzi improved survival and reduced the rate at which patients experience disease recurrence or progression,” she added. “We are eager to bring this regimen with the potential to transform the standard of care to patients as soon as possible.”
Imfinzi, which already holds approvals in lung cancer, biliary tract cancer, endometrial cancer and hepatocellular carcinoma, is a human monoclonal antibody designed to block the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.
The therapy was approved by the US Food and Drug Administration earlier this month as part of a combination regimen with carboplatin and paclitaxel to treat adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient.
The regulator’s decision was supported by positive results from the late-stage DUO-E trial, in which the Imfinzi combination reduced the risk of disease progression or death by 58% versus chemotherapy alone.