NEW STUDY RESULTS SHOW that adding an immunotherapy drug called Imfinzi (durvalumab) to treatment with chemotherapy and surgery improved event-free survival and overall survival in patients with muscle-invasive bladder cancer. The findings, presented in September at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, could offer another tool against a disease that is notoriously difficult to treat and frequently returns.

For many years, the standard of care for eligible muscle-invasive bladder cancer patients has been chemotherapy followed by a radical cystectomy to remove the whole bladder. The new study, a phase III trial called NIAGARA, aimed to evaluate if these patients would do better when given Imfinzi alongside chemotherapy before surgery, as well as Imfinzi again after surgery.

From November 2018 to July 2021, the trial enrolled 1,063 patients across 22 countries. A total of 533 patients were given the Imfinzi regimen, while 530 were in a control group that received just neoadjuvant chemotherapy and surgery. The Imfinzi group was given neoadjuvant chemotherapy plus the immunotherapy every three weeks for four cycles before surgery and Imfinzi alone every four weeks for eight cycles after surgery. The control group received chemotherapy alone before surgery.

At 24 months, 67.8% of patients in the Imfinzi group did not have cancer progress or return, compared with 59.8% in the control group. Overall survival was also better in the Imfinzi group, with 82.2% alive at 24 months compared with 75.2% in the control group. Serious treatment-related side effects occurred at roughly the same rate in both groups.

“Early immune therapy saves lives,” Thomas Powles, the lead study investigator and director of Barts Cancer Centre at St. Bartholomew’s Hospital in London, says of the trial’s findings.

He explains that the results could be considered groundbreaking. “The drug has a survival signal and opens a new chapter in treatment for the disease,” Powles says. As researchers learn more about using immunotherapy in this patient population, he adds, the need for surgery may decrease.

Max Kates, a urologic oncologist at Johns Hopkins Medicine in Baltimore, Maryland, stresses the importance of the findings for a disease that has not seen much treatment progress in decades.

“What they show is that we’re increasingly able to achieve complete responses in a portion of patients with muscle-invasive bladder cancer,” says Kates, who was not involved with the NIAGARA trial. “The implications of that will be felt by our patients for many years to come.”

However, Kates clarifies that in the real-world application of these findings, doctors may be less inclined to recommend that patients add Imfinzi to their treatment plans both before and after surgery.

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“Before therapy, yes. After therapy, we will see,” Kates explains.

Laura Bukavina, a urologist at Cleveland Clinic Cancer Center who was not involved in the NIAGARA trial, stresses that even with the trial’s statistically significant results, “critical questions remain.”

There is a debate about whether “this approach risks overtreating a portion of patients, exposing them to unnecessary therapy and potential long-term side effects without clear benefit,” Bukavina explains. “Additionally, the trial did not clarify whether the observed benefits were driven by the neoadjuvant or adjuvant use of [Imfinzi]—or a combination of both—leaving uncertainty about the optimal approach.”

Bukavina urges patients to interpret the NIAGARA trial results with caution and to consider risks such as “immune-mediated adverse events and financial toxicity.” According to Powles, more research is underway to understand exactly when and for how long immunotherapy should be given to this patient population. As more data come in, he explains, the hope is that treatment can be effectively administered before patients undergo surgery.

Laura Gesualdi-Gilmore is a Chicago-based freelance journalist who covers topics ranging from health and wellness to luxury travel.