Health Canada approves perioperative durvalumab/Infinifer plus chemotherapy for MIBC

Health Canada has approved neoadjuvant durvalumab/Infinifer (Durvalumab) in combination with gemcitabine and cisplatin, followed by approval of adjuvant durvalumab monotherapy in adult patients with muscle-invasive bladder cancer (MIBC) after radical cystectomy. This marks the first and only approval of perioperative immunotherapy in this setting in Canada. In March 2025, the United States also approved perioperative durvalumab combined with chemotherapy.

Health Canada's approval of thisdurvalumab-based perioperative regimen is a significant advance for Canadians with muscle-invasive bladder cancer, in which nearly half of patients will relapse despite treatment. The approval was supported by results from the NIAGARA Phase 3 trial (NCT03732677), which showed that perioperative durvalumab plus neoadjuvant chemotherapy prolonged event-free survival (EFS) and overall survival (OS) compared with neoadjuvant chemotherapy alone.

At 24 months, the estimated EFS was 67.8% (95% CI, 63.6 to 71.7) in the durvalumab group compared with 59.8% (95% CI, 55.4 to 64.0) in the control group (HR, 0.68; 95% CI, 0.56 to 0.82; P<0.001). Median EFS was not reached in the durvalumab group and was 46.1 months in the chemotherapy group (95% CI: 32.2, NR). During a median follow-up of 42.3 months, 35.1% of patients in the durvalumab group and 46.4% of patients in the control group experienced an EFS event.

In addition, the estimated OS at 24 months was 82.2% (95% CI, 78.7 to 85.2) in the durvalumab group compared with 75.2% (95% CI, 71.3 to 78.8) in the control group (HR, 0.75; 95% CI, 0.59 to 0.93; P=0.011). Median OS was not reached in either arm. Pathological complete response (pCR), the second primary endpoint of the trial, was not significantly different between the two groups. Specifically, the pCR rate was 33.8% (95% confidence interval [CI], 29.8 to 38.0) in the durvalumab group compared with 25.8% (95% CI, 22.2 to 29.8) in the control group (RR, 1.30; 95% CI, 1.09 to 1.56; P=0.004).

Durvalumab was generally well tolerated and no new safety signals were observed. Adverse events (AEs) were also comparable between the two groups. Grade 3 to 4 adverse events occurred in 69.4% of patients in the durvalumab group and 67.5% of patients in the control group. Grade 3-4 treatment-related adverse events were reported by 40.6% and 40.9% of patients, respectively. Radical cystectomy was performed in 88.0% of patients in the durvalumab group and 83.2% in the control group.

Overall, the open-labelNIAGARA trial enrolled 1,063 adult patients with MIBC who were cisplatin-resistant, candidates for radical cystectomy, and who had not received prior systemic therapy for the cancer. Participants were randomized 1:1 to receive neoadjuvant durvalumab plus gemcitabine-cisplatin every 3 weeks for 4 cycles, followed by radical cystectomy, to receive adjuvant durvalumab every 4 weeks for 8 cycles (n = 533), or to receive neoadjuvant gemcitabine-cisplatin every 4 weeks for 8 cycles (n = 530).

The dual primary endpoints areEFS and pCR. OS is a key secondary endpoint. The high recurrence rates associated with muscle-invasive bladder cancer are an ongoing challenge and a concern for physicians and patients. Health Canada's approval, based on the NIAGRA trial results, may now provide the opportunity to increase the patient's chance of better outcomes and long-term survival by using immunotherapy in this setting, which is very good news for patients and their families.

Reference materials:https://www.imfinzi.com/