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The first immunotherapy shown to improve survival when given around bladder-removal surgery.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,063 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free survivalprimary | Durvalumab + chemo, perioperative | 533 | median not reached | 0.68 (0.56 to 0.82) | <0.001 | link |
| Chemo + cystectomy | 530 | 46.1 months | ||||
| Overall survival | Durvalumab arm | - | not reached | 0.75 (0.59 to 0.93) | 0.01 | link |
| Control | - | not reached |
Shares Radical cystectomy, Non-muscle-invasive vs muscle-invasive bladder cancer (NMIBC / MIBC), Bladder & urothelial cancer.
Shares Muscle-invasive and advanced bladder cancer, Durvalumab, AstraZeneca, Bladder & urothelial cancer.
Shares Non-muscle-invasive vs muscle-invasive bladder cancer (NMIBC / MIBC), Durvalumab, AstraZeneca, Bladder & urothelial cancer.
Shares Radical cystectomy, Non-muscle-invasive vs muscle-invasive bladder cancer (NMIBC / MIBC), Bladder & urothelial cancer.
Shares Muscle-invasive and advanced bladder cancer, Durvalumab, AstraZeneca, Bladder & urothelial cancer.
Shares Thomas Powles, Muscle-invasive and advanced bladder cancer, Neoadjuvant / adjuvant / perioperative, Durvalumab.
Shares Muscle-invasive and advanced bladder cancer, Durvalumab, AstraZeneca, Bladder & urothelial cancer.
Shares Muscle-invasive and advanced bladder cancer, Durvalumab, AstraZeneca, Bladder & urothelial cancer.