ESMO 2025 | Evaluating durvalumab and chemotherapy for MIBC in the NIAGARA trial
Alexandra Drakaki, MD, PhD, University of California, Los Angeles, CA, discusses the results of the Phase III NIAGARA study (NCT03732677), which demonstrated a significant improvement in pathologic complete response and overall survival with the addition of durvalumab to cisplatin and gemcitabine in patients with muscle-invasive bladder cancer (MIBC). The study allowed patients with reduced renal function to participate and receive split doses of platinum with gemcitabine, and also found that neoadjuvant immunotherapy improved ctDNA clearance compared to the control arm. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.
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Transcript
NIAGARA is a phase 3 global study in which patients who are cisplatin eligible with muscle-invasive disease were randomized to receive cisplatin gemcitabine durvalumab versus cisplatin gemcitabine alone. After a cystectomy, patients were able on the study arm to continue with durvalumab to complete a year. And what was impressive and different and very special on the study is that patients with creatinine clearance between 40 and 60, they were still allowed to participate in the study...
NIAGARA is a phase 3 global study in which patients who are cisplatin eligible with muscle-invasive disease were randomized to receive cisplatin gemcitabine durvalumab versus cisplatin gemcitabine alone. After a cystectomy, patients were able on the study arm to continue with durvalumab to complete a year. And what was impressive and different and very special on the study is that patients with creatinine clearance between 40 and 60, they were still allowed to participate in the study. And specifically, they had the chance to receive split doses of platinum with gemcitabine. So we’re able to see a significant improvement in pathologic complete CR with the addition of the durvalumab and also in overall survival. We also have data on the ctDNA status, and we found when patients receive neoadjuvant component with immunotherapy, the immunotherapy improved the ctDNA clearance by an extra 13% compared to the control arm. And so as of March of 2025, this is in the NCCN guidelines. It’s an FDA-approved approach for patients with cisplatin-eligible muscle-invasive bladder cancer.
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