{"entity":{"id":"niagara","kind":"trial","name":"NIAGARA","aka":[],"tldr":"The first immunotherapy shown to improve survival when given around bladder-removal surgery.","summary":"NIAGARA, trial NCT03732677 sponsored by AstraZeneca and reported in 2024, was the first trial to show that immunotherapy given around bladder-removal surgery improves survival. It randomised 1,063 cisplatin-eligible patients with muscle-invasive bladder cancer to neoadjuvant durvalumab plus gemcitabine and cisplatin, cystectomy and adjuvant durvalumab, or neoadjuvant chemotherapy and cystectomy, met its primary event-free survival endpoint, improved overall survival and raised the pathologic complete response rate, leading to FDA approval on 28 March 2025 as the first perioperative immunotherapy in this disease. OnCo links it to bladder cancer, durvalumab, the perioperative, MIBC and radical cystectomy terms and Thomas Powles. It sets a new baseline that EV-304 now challenges, and which regimen wins is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03732677","url":"https://clinicaltrials.gov/study/NCT03732677"},{"label":"FDA approval (Mar 2025)","url":"https://www.urologytimes.com/view/fda-approves-durvalumab-chemo-for-muscle-invasive-bladder-cancer"}],"tags":[],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant","nmibc-vs-mibc"],"trials":[],"people":["thomas-powles"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03732677","phase":"3","setting":"Cisplatin-eligible muscle-invasive bladder cancer: neoadjuvant durvalumab + gemcitabine-cisplatin, cystectomy, adjuvant durvalumab vs neoadjuvant chemotherapy and cystectomy","sponsor":"AstraZeneca","result":"EFS HR 0.68; OS HR 0.75.","started":"2018-11-16","startedType":"actual","yearReported":2024,"enrolled":1063,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival","primary":true,"unit":"months","arms":[{"name":"Durvalumab + chemo, perioperative","n":533,"note":"median not reached"},{"name":"Chemo + cystectomy","n":530,"value":46.1}],"hr":0.68,"ci":[0.56,0.82],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2408154"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Durvalumab arm","note":"not reached"},{"name":"Control","note":"not reached"}],"hr":0.75,"ci":[0.59,0.93],"p":"0.01","source":"https://doi.org/10.1056/NEJMoa2408154"}],"replication":"Perioperative IO benefit replicated in principle by EV-303 and EV-304 (with an ADC partner) and by adjuvant CheckMate 274."},"route":"/trials/niagara/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"muscle-invasive-bladder-cancer","kind":"cancer","name":"Muscle-invasive and advanced bladder cancer","route":"/cancers/muscle-invasive-bladder-cancer/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"durvalumab","kind":"drug","name":"Durvalumab","route":"/drugs/durvalumab/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"term":[{"id":"neoadjuvant-adjuvant","kind":"term","name":"Neoadjuvant / adjuvant / perioperative","route":"/terms/neoadjuvant-adjuvant/"},{"id":"nmibc-vs-mibc","kind":"term","name":"Non-muscle-invasive vs muscle-invasive bladder cancer (NMIBC / MIBC)","route":"/terms/nmibc-vs-mibc/"},{"id":"cystectomy","kind":"term","name":"Radical cystectomy","route":"/terms/cystectomy/"}],"person":[{"id":"thomas-powles","kind":"person","name":"Thomas Powles","route":"/people/thomas-powles/"}],"roadmap":[{"id":"surgery-roadmap","kind":"roadmap","name":"Surgery roadmap: radical operations → less surgery → no surgery when a drug has done the work","route":"/roadmaps/surgery-roadmap/"}]}}