Editing Muscle-Invasive Bladder Cancer (section)

===== <span style="color:#ff00ff">NIAGARA (neoadjuvant/adjuvant darvalumab)</span> =====

* Population: 503 patients with muscle-invasive bladder cancer, cT2-4a, N0-1, M0, and eligible for cisplatin-based chemotherapy 
* Randomized 1:1 to four cycles of neoadjuvant durvalumab with gemcitabine–cisplatin every 3 weeks, followed by radical cystectomy and then up to eight cycles of adjuvant durvalumab administered intravenously every 4 weeks vs. neoadjuvant gemcitabine–cisplatin followed by radical cystectomy alone
* Co-Primary Outcomes:
** Pathological complete response
** Event-free survival, defined as the time from randomization to progressive disease that precluded radical cystectomy, the first recurrence of disease after radical cystectomy, the expected date of surgery (in patients who did not undergo radical cystectomy), or death from any cause.
* Results
** Pathological complete response benefit: 8% (33.8% darvalumab vs. 25.8% comparison)
** Event-free survival at 24 months benefit: 8% (67.8% darvalumab vs. 59.8% comparison)
* [https://pubmed.ncbi.nlm.nih.gov/39282910/ Powles, Thomas, et al. "Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer." ''The New England journal of medicine'' (2024): 1-14.]