N Engl J Med

ESMO 2024: Does durvalumab improve bladder cancer survival outcomes?

September 18, 2024

Perioperative durvalumab plus neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer (MIBC) significantly improved event-free survival and overall survival vs. neoadjuvant chemotherapy alone. The findings were shared at the European Society for Medical Oncology (ESMO) congress in Spain.

• In the phase 3, open-label, randomized NIAGARA trial, cisplatin-eligible patients with MIBC were assigned to receive neoadjuvant durvalumab plus gemcitabine-cisplatin q3wks for four cycles, followed by radical cystectomy and adjuvant durvalumab q4wks for eight cycles (durvalumab group, N=533), or to receive neoadjuvant gemcitabine-cisplatin followed by radical cystectomy alone (comparison group, n=530).
• The estimated event-free survival at 24 months was 67.8% in the durvalumab group and 59.8% in the comparison group. The estimated overall survival at 24 months was 82.2% and 75.2% in the durvalumab and comparison groups, respectively.
• Treatment-related adverse events of grade 3 or 4 in severity occurred in 40.6% of the patients in the durvalumab group and in 40.9% of those in the comparison group; treatment-related adverse events leading to death occurred in 0.6% in each group. Radical cystectomy was performed in 88.0% of the patients in the durvalumab group and in 83.2% of those in the comparison group.

Source:

Powles T, et al; NIAGARA Investigators. (2024, September 15). N Engl J Med. Perioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer. https://pubmed.ncbi.nlm.nih.gov/39282910/