The FDA has approved Imfinzi (durvalumab) for two bladder cancer treatment settings: muscle-invasive bladder cancer (MIBC) and BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). In MIBC, durvalumab is given with gemcitabine and cisplatin chemotherapy before bladder removal surgery and then continued alone after surgery. This perioperative approach improves cancer-free survival and overall survival compared with chemotherapy before surgery alone. In high-risk NMIBC, durvalumab is given with BCG, a standard bladder-directed immunotherapy, for patients whose cancer has not grown into the bladder muscle but has features that make it more likely to come back or progress.
In a more recent bladder cancer approval, the FDA approved Imfinzi in combination with BCG for adults with BCG-naïve, high-risk non-muscle invasive bladder cancer. This expands the role of durvalumab beyond muscle-invasive bladder cancer, where it is already used with chemotherapy before surgery and continued after surgery. In the POTOMAC clinical trial, adding durvalumab to BCG helped patients live longer without their cancer returning, worsening, becoming muscle-invasive or metastatic, or causing death compared with BCG alone. Patients with high-risk non-muscle invasive bladder cancer should ask their doctor whether BCG alone or BCG with durvalumab may be appropriate based on their tumor features, prior treatment history, overall health, and treatment goals.
About Imfinzi (durvalumab)
Imfinzi is a precision cancer immunotherapy designed to bind with a protein called PD-L1, which may be expressed on cancer cells and immune cells in the tumor environment. By blocking the interaction between PD-L1 and PD-1, Imfinzi may help activate T cells so the immune system can better recognize and attack cancer. In addition to bladder cancer, Imfinzi is also FDA approved for appropriate patients with non-small cell lung cancer, small cell lung cancer, biliary tract cancer, and hepatocellular carcinoma.
Key details for patients with muscle-invasive bladder cancer
Treatment plan: Patients receive 4 cycles of durvalumab plus gemcitabine and cisplatin chemotherapy before bladder removal surgery, followed by 8 cycles of durvalumab alone after surgery.
In the pivotal NIAGARA clinical trial, this approach:
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Reduced the risk of cancer returning or death by 32% compared with chemotherapy treatment alone.
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Showed a 25% lower risk of death from any cause.
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Increased complete tumor disappearance before surgery, also called pathologic complete response, from 28% with chemotherapy alone to 37% with durvalumab plus chemotherapy.
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Improved longer-term outcomes, with 68% of patients remaining cancer-free at 2 years compared with 60% of patients treated with standard chemotherapy.
Combining immunotherapy with traditional chemotherapy to attack cancer before surgery and help prevent recurrence afterward represents an important treatment advance for patients with MIBC. Patients should consult with their urologist and oncology team about whether this treatment plan suits their specific condition and medical history. One key question to discuss is whether all patients need to have their bladder removed as part of the overall treatment plan. New research suggests that circulating tumor DNA, or ctDNA, may help doctors determine which patients may be able to avoid bladder-removing surgery, also called radical cystectomy.
Key details for patients with high-risk non-muscle invasive bladder cancer
Treatment plan: Patients receive durvalumab in combination with BCG induction and maintenance therapy. BCG is a treatment placed directly into the bladder and has long been a standard option for high-risk non-muscle invasive bladder cancer.
In the pivotal POTOMAC clinical trial, this approach:
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Reduced the risk of cancer recurrence, progression, or death by 32% compared with BCG alone.
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Helped patients live longer without high-risk NMIBC returning.
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Delayed or reduced events such as persistent carcinoma in situ, progression to muscle-invasive bladder cancer, metastatic disease, or death.
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Had not yet reached the median time patients lived without disease in either treatment group at the time of analysis, meaning more than half of patients in both groups were still disease-free.
This approval is important because high-risk NMIBC can return after treatment or progress to a more serious stage. Patients who are newly diagnosed with high-risk NMIBC and have not previously received BCG should ask their doctor whether adding durvalumab to BCG may be appropriate.
Safety considerations
Common side effects of durvalumab-based treatment may include fatigue, nausea, and cough. Serious immune-related reactions can also occur because immunotherapy can cause the immune system to attack healthy organs or tissues. Patients will be closely monitored for potential complications such as lung inflammation, thyroid problems, infusion reactions, and other immune-related side effects.
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References
Powles T, Catto JWF, Galsky MD, et al; NIAGARA Investigators. Perioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer. N Engl J Med. 2024 Nov 14;391(19):1773-1786.
