NIAGARA Trial: A New Standard of Care in MIBC
Key Points
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Perioperative durvalumab with neoadjuvant chemotherapy should be the standard of care for resectable muscle-invasive bladder cancer (MIBC).
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The benefit of the adjuvant durvalumab doses is uncertain, although circulating tumor DNA (ctDNA) data may be able to guide treatment decision-making.
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Patient eligibility should be considered with neoadjuvant chemotherapy.
At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, Michael Serzan, MD, of Dana-Farber Cancer Institute, spoke with Petros Grivas, MD, PhD, of Fred Hutchinson Cancer Institute and UW Medicine, about the results of the NIAGARA trial in MIBC.
Resectable MIBC has historically been treated with neoadjuvant chemotherapy, followed by radical cystectomy with lymph node dissection and then by adjuvant nivolumab. The NIAGARA trial showed a benefit with 4 cycles of durvalumab and gemcitabine-cisplatin chemotherapy prior to surgery, plus up to 8 monthly doses of adjuvant durvalumab after surgery.
Dr. Grivas advocated for the NIAGARA regimen as the standard of care in immunotherapy- and cisplatin-eligible patients, while acknowledging the ongoing uncertainty of the adjuvant durvalumab component. “You have to worry about overtreatment—toxicity and cost—but also worry about undertreatment,” he said.
He considered that ctDNA may be able to guide adjuvant therapy decision-making in the future and highlighted analyses being presented at the meeting that assessed ctDNA in the NIAGARA data set.
Dr. Grivas emphasized that this regimen is appropriate only for cisplatin-eligible patients with resectable MIBC, adding that its use in clinical practice may depend on how oncologists interpret and apply creatinine clearance cutoffs.