Health Canada approves perioperative durvalumab plus chemo for MIBC

Health Canada has granted approval to neoadjuvant durvalumab (Imfinzi) in combination with gemcitabine and cisplatin, followed by adjuvant durvalumab monotherapy following radical cystectomy for adult patients with muscle–invasive bladder cancer (MIBC), AstraZeneca announced in a news release.¹

This marks the first and only approval of a perioperative immunotherapy in this setting in Canada. Perioperative durvalumab in combination with chemotherapy was also approved in the US in March 2025.

"Health Canada's approval of this durvalumab-based perioperative regimen represents a major advance for Canadians with muscle invasive bladder cancer, where nearly half will relapse despite curative treatment," said Srikala Sridhar, MD, MSc, FRCPC, professor of medicine at the University of Toronto and genitourinary medical oncologist at the Princess Margaret Cancer Centre, in the news release.¹

The approval is supported by results from the phase 3 NIAGARA trial (NCT03732677), which showed that perioperative durvalumab plus neoadjuvant chemotherapy extended event-free survival (EFS) and overall survival (OS) vs neoadjuvant chemotherapy alone.²

At 24 months, the estimated EFS was 67.8% (95% CI, 63.6 to 71.7) in the durvalumab arm vs 59.8% (95% CI, 55.4 to 64.0) in the comparator arm (HR, 0.68; 95% CI, 0.56 to 0.82; P < .001). The median EFS was not reached in the durvalumab arm and was 46.1 months (95% CI: 32.2, NR) in the chemotherapy arm. At a median follow-up of 42.3 months, 35.1% of patients in the durvalumab arm and 46.4% of patients in the comparator arm experienced an EFS event.

Further, the estimated 24-month OS was 82.2% (95% CI, 78.7 to 85.2) in the durvalumab arm vs 75.2% (95% CI, 71.3 to 78.8) in the control arm (HR, 0.75; 95% CI, 0.59 to 0.93; P = .011). The median OS has not been reached in either arm.

Pathological complete response (pCR), the trial’s second primary end point, was not significantly different between both arms. Specifically, the pCR rate was 33.8% (95% confidence interval [CI], 29.8 to 38.0) in the durvalumab arm vs 25.8% (95% CI, 22.2 to 29.8) in the control arm (RR, 1.30; 95% CI, 1.09 to 1.56; P = .004).

Durvalumab was generally well-tolerated, with no new safety signals observed. Adverse events (AEs) were also comparable between both arms.

Grade 3 to 4 AEs occurred in 69.4% of patients in the durvalumab arm and 67.5% of patients in the control arm. Grade 3-4 treatment-related AEs were reported in 40.6% and 40.9% of patients, respectively.

The authors also reported, “Radical cystectomy was performed in 88.0% of the patients in the durvalumab group and in 83.2% of those in the comparison group.”

In total, the open-label NIAGARA trial enrolled 1063 adult patients with MIBC who were cisplatin-eligible, candidates for radical cystectomy, and had not received prior systemic therapy for bladder cancer. Participants were randomly assigned 1:1 to receive neoadjuvant durvalumab plus gemcitabine-cisplatin every 3 weeks for 4 cycles followed by radical cystectomy and adjuvant durvalumab every 4 weeks for 8 cycles (n = 533) or to receive neoadjuvant gemcitabine-cisplatin followed by radical cystectomy alone (n = 530).

The dual primary end points were EFS and pCR. OS was a key secondary end point.

"The high rate of recurrence associated with muscle invasive bladder cancer is an ongoing challenge and source of concern for physicians and patients," said Normand Blais, MD, MSc, medical oncologist at the Centre hospitalier de l'Université de Montréal, in the news release.¹ "The Health Canada approval based on results from the NIAGARA trial may now offer us the opportunity to increase the chance of better patient outcomes and long-term survival by the use of immunotherapy in this setting, which is very good news for patients and their families."

REFERENCES

1. Imfinzi approved in Canada as first and only perioperative immunotherapy for muscle invasive bladder cancer. News release. AstraZeneca Canada, Inc. August 6, 2025. Accessed August 11, 2025. https://www.biospace.com/press-releases/imfinzi-approved-in-canada-as-first-and-only-perioperative-immunotherapy-for-muscle-invasive-bladder-cancer

2. Powles T, Catto JWF, Galsky MD. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. N Engl J Med. 2024;391:1773-1786. doi:10.1056/NEJMoa2408154