The FDA has approved a new treatment option for muscle-invasive bladder cancer (MIBC) that clearly improves outcomes. Durvalumab (Imfinzi), used before and after surgery administered in combination with the chemotherapy drugs gemcitabine and cisplatin improves cancer free survival.
About Imfinzi (durvalumab)
Imfinzi is a precision cancer immunotherapy designed to bind with a protein called PD-L1, which is expressed on cancer cells and tumor-infiltrating immune cells, blocking its interaction with the PD-1 receptor. By inhibiting PD-L1, Imfinzi may enable the activation of T cells. In addition for approval in the treatment of patients with muscle-invasive bladder cancer, Imfinzi is also FDA approved in appropriate patients with NSCLC, SCLC, biliary tract cancer, and hepatocellular carcinoma.
Key details for patients:
- Treatment plan: Patients receive 4 cycles of durvalumab + chemotherapy before bladder removal surgery, followed by 8 cycles of durvalumab alone after surgery.
- In a pivotal clinical trial, this approach:
- Reduced the risk of cancer returning or death by 32% when compared to chemotherapy treatment alone.
- Showed 25% lower risk of death from any cause
- Increased complete tumor disappearance before surgery (37% vs 28% with chemo alone)
- Longer-term results: 68% of patients remained cancer-free at 2 years with the addition of durvalumab immunotherapy compared to vs 60% with standard chemotherapy.
Combining immunotherapy with traditional chemotherapy to attack cancer before surgery and help prevent recurrence afterward is a new standard and patients with MIBC should consult with their urologist about whether this treatment plan suits their specific condition and medical history. A key questions to discuss is whether all patients need to have their bladder removed as part of the overall treatment plan? New research suggests that ctDNA may help doctors determine which patients may not need to undergo bladder removing surgical cystectomy.
Safety considerations:
Common side effects include fatigue, nausea, and cough. While serious immune-related reactions can occur, clinical trials showed similar safety profiles to standard chemotherapy. Patients will be closely monitored for potential complications like lung inflammation or thyroid issues.
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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.
