Imfinzi (durvalumab) Before and After Surgery in Muscle-Invasive Bladder Cancer: What the NIAGARA Trial Showed

The New England Journal of Medicine has published the results of the phase III NIAGARA trial in patients with resectable muscle-invasive bladder cancer who are eligible for cisplatin treatment. The trial compared standard neoadjuvant chemotherapy with gemcitabine and cisplatin against a perioperative approach in which Imfinzi (durvalumab) was added to chemotherapy before surgery, and then Imfinzi (durvalumab) was continued after radical cystectomy. The regimen with Imfinzi (durvalumab) showed improvement in both event-free and overall survival. Imfinzi (durvalumab) is registered in Russia.

In brief: what happened

The trial enrolled 1,063 patients with operable muscle-invasive bladder cancer who were eligible for cisplatin.

• Patients received either Imfinzi (durvalumab) together with gemcitabine and cisplatin before surgery, and then Imfinzi (durvalumab) after cystectomy, or standard chemotherapy before surgery without further adjuvant durvalumab.
• At 24 months, event-free survival was 67.8% in the Imfinzi (durvalumab) group versus 59.8% in the control group.
• At 24 months, overall survival was 82.2% versus 75.2% respectively.

Key numbers from the trial

The main result of the trial was a 32% reduction in the risk of an event by event-free survival: HR 0.68; p<0.001. For overall survival, the risk of death was reduced by 25%: HR 0.75; p=0.01. The rate of treatment-related grade 3–4 adverse events was practically the same in both groups: 40.6% versus 40.9%, and treatment-related fatal events occurred in 0.6% in each group. It is also important that radical cystectomy was performed in 88.0% of patients in the Imfinzi (durvalumab) group and in 83.2% in the standard treatment group, meaning that adding immune therapy did not disrupt the surgical stage.

Why this matters in practice

For patients who are eligible for cisplatin and are proceeding to radical cystectomy, neoadjuvant chemotherapy before surgery has long remained the standard. NIAGARA showed that a perioperative approach with Imfinzi (durvalumab) can improve outcomes not only for event-free survival but also for overall survival. This matters in practice because the discussion of treatment before surgery now becomes broader: it is no longer only about whether chemotherapy is needed before cystectomy, but also about whether a perioperative regimen with immune therapy should be discussed for a specific patient.

Limitations / what does not change yet

These results cannot be automatically extended to all patients with bladder cancer. The trial enrolled only patients with resectable muscle-invasive bladder cancer who were eligible for cisplatin treatment and were being considered for radical cystectomy. This is not a trial for metastatic disease, not for patients with contraindications to cisplatin, and not for situations where a different treatment route was chosen from the outset. In addition, the trial does not answer the question of how large the individual contribution of the postoperative Imfinzi (durvalumab) stage is compared with the preoperative part of the regimen. Chemotherapy and surgery still remain the foundation of treatment.

When a second opinion is especially useful

• you are offered surgery right away without discussing systemic treatment beforehand;
• there are doubts about whether you are eligible for cisplatin;
• different clinics propose different treatment routes;
• you want to understand whether a perioperative regimen with Imfinzi (durvalumab) applies to your situation;
• it is important for you to assess not only the next stage of treatment, but the entire strategy as a whole.

What to prepare for the consultation

To make the review truly substantive, it is best to gather in advance:

• the histopathology report;
• the discharge summary after transurethral resection of the bladder or another procedure that confirmed the diagnosis;
• the most recent CT, MRI or PET-CT, if performed;
• a discharge summary indicating the stage and the proposed treatment plan;
• blood tests, including indicators of kidney function;
• a list of comorbidities and medications taken.

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