The review is for Imfinzi (durvalumab) injection 120MG/2.4ML solution for previously untreated – Stage IIIA Muscle Invasive Bladder Cancer. The U.S. Food and Drug Administration (FDA) recently announced that it has approved durvalumab (Imfinzi), a new immune checkpoint inhibitor, for the treatment of certain patients with urothelial carcinoma – the most common form of bladder cancer. It is to be given together with cisplatin and Gemzar. The neoadjuvant cisplatin/ gemcitabine regimen is standard for bladder cancer, and recommended by NCCN. Its combination with Infinzi for this setting is not listed by NCCN BL-G6 of 7. Howeverm its approval by\y the FDA is expected.
At the ESMO Congress 2024, held in Barcelona, Spain, September 13–17, researchers reported that patients who received the PD-L1 inhibitor durvalumab (Imfinzi; AstraZeneca) and cisplatin–gemcitabine prior to surgery, followed by adjuvant durvalumab, experienced statistically significant and clinically meaningful improvements in survival compared with neoadjuvant cisplatin–gemcitabine alone . The estimated event-free survival at 24 months among the patients who received durvalumab was 67.8% and 59.8% in the group that received standard therapy. Estimated overall survival at 24 months was 82.2% and 75.2%, respectively.
Advanced Bladder Cancer (ABC) Meta-analysis Collaboration. Neoadjuvant Chemotherapy in Invasive Bladder Cancer:Review and Meta-analysis. Lancet 2003;361:1927-34
NCCN.ORG, Bladder cancer BL-G, 2024
T. Powles et a,Perioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer. N Engl J Med 2024;391:1773-1786
DOI: 10.1056/NEJMoa2408154
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