The phase 3 open-label, randomized NIAGARA trial was designed to evaluate the benefits of adding perioperative immunotherapy durvalumab to standard neoadjuvant cisplatin-based combination chemotherapy (cisplatin plus gemcitabine).
Presented by Thomas Powles from Barts Cancer Institute, London, UK, during Presidential Session II at the ESMO Congress 2024 (13-17 September, Barcelona) results of this study show for the first time that the addition of durvalumab before surgery (radical cystectomy) and durvalumab monotherapy after surgery in patients with localized muscle-invasive bladder cancer significantly improved event-free survival and overall survival compared with neoadjuvant chemotherapy alone. These data published concurrently in The New England Journal of Medicine*.
“The NIAGARA clinical trial recruited a total of 1,063 cisplatin-eligible patients planned to undergo radical cystectomy, which is currently the standard of care,” said Cristina Suárez, a co-author of this present study, Medical Oncologist at Vall d’Hebron and a Clinical Investigator of VHIO’s Genitourinary, CNS and Sarcoma Group.
Patients were randomised (1:1) to receive neoadjuvant durvalumab plus neoadjuvant chemotherapy followed by surgery then adjuvant durvalumab monotherapy, or neoadjuvant chemotherapy followed by surgery alone.
The estimated event-free survival at 24 months was 67.8% in the durvalumab group, and 59.8% in the control, and overall survival at 24 months was 82.2% in the durvalumab group and 75.2% in the comparison group. This represents a 32% benefit in event-free survival and 25% benefit in overall survival in patients treated with the novel combination compared to those who received standard of care. Complete response rate was 37% in the durvalumab arm and 27% in the standard treatment group.
“Notably, the toxicity profile of perioperative durvalumab with neoadjuvant chemotherapy was manageable and as expected for checkpoint inhibitors and chemotherapy, with no new adverse treatment events. Based on the practice changing results and upon evaluation by the different regulatory authorities and healthcare reimbursement systems, this novel treatment approach should be the new standard of care for cisplatin-eligible patients with localized muscle-invasive bladder cancer,” added Suárez.
“Over the last two decades, neoadjuvant cisplatin-based combination chemotherapy followed by surgery has been standard of care in this patient population,” observed Rafael Morales, Medical Oncologist at Vall d’Hebron and Clinical Investigator of VHIO’s Genitourinary, CNS and Sarcoma Group.
“However, approximately 50% of patients will develop and suffer from disease recurrence. This new therapeutic strategy could improve survival and quality of life in patients with muscle-invasive bladder cancer,” concluded Morales.
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Reference
Session details
ESMO Congress 2024
LBA5 – Powles TB, et al. A randomized phase 3 trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer (NIAGARA).
Presidential Symposium II – Practice-changing trials
Date: 15.09.2024
Time 16:30 – 17:50h
Barcelona Auditorium – Hall 2
