NIAGARA
The first immunotherapy shown to improve survival when given around bladder-removal surgery.
EFS HR 0.68 (median not reached vs 46.1 months); OS HR 0.75; pCR 37.3% vs 27.5%. FDA approval 28 March 2025, the first perioperative immunotherapy for MIBC. Establishes a new baseline that EV-304 now challenges.
- Median 46.1 months with Chemo + cystectomy.
- Durvalumab + chemo, perioperative: median not reached.
- "Not reached" means that, when the data were analysed, more than half of that group had not yet had the event, which is good news for that group.
- A median is a midpoint: half the people did better than this and half did worse.
- Put another way, the treated group had about 32 percent lower chance of the event at any given time (hazard ratio 0.68, likely range 0.56 to 0.82).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- The treated group had about 25 percent lower chance of the event at any given time (hazard ratio 0.75).
- The absolute difference, how many more people out of 100 were helped, is not reported here.
- not reached not reached
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Cisplatin-eligible muscle-invasive bladder cancer: neoadjuvant durvalumab + gemcitabine-cisplatin, cystectomy, adjuvant durvalumab vs neoadjuvant chemotherapy and cystectomy. People in a different situation may not see the same effect.
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 participants enrolled.
median not reached
Sourcenot reached · not reached
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free survivalprimary | Durvalumab + chemo, perioperative | 533 | median not reached | 0.68 (0.56–0.82) | <0.001 | link |
| Chemo + cystectomy | 530 | 46.1 months | ||||
| Overall survival | Durvalumab arm | — | not reached | 0.75 (0.59–0.93) | 0.01 | — |
| Control | — | not reached |
Pages like this
not linked directly; found by shared links- TermTransurethral resection of bladder tumour (TURBT)
Shares Muscle-invasive (MIBC) vs non-muscle-invasive (NMIBC) bladder cancer, Radical cystectomy, Bladder & urothelial cancer.
- TermIntravesical therapy (BCG and bladder instillations)
Shares Muscle-invasive (MIBC) vs non-muscle-invasive (NMIBC) bladder cancer, Radical cystectomy, Bladder & urothelial cancer.
- TrialPOTOMAC
Shares Non-muscle-invasive vs muscle-invasive bladder cancer (NMIBC / MIBC), Durvalumab, Bladder & urothelial cancer.
- TechnologyCystoscopy, blue-light imaging & TURBT
Shares Non-muscle-invasive vs muscle-invasive bladder cancer (NMIBC / MIBC), Bladder & urothelial cancer.
- TermStoma (colostomy, ileostomy, urostomy)
- TermOrgan preservation (watch-and-wait, bladder-sparing, larynx preservation)
Shares Muscle-invasive (MIBC) vs non-muscle-invasive (NMIBC) bladder cancer, Radical cystectomy, Bladder & urothelial cancer.
- PairingDurvalumab + BCG in BCG-naive high-risk NMIBC
Shares Durvalumab, Bladder & urothelial cancer.
- TrialMATTERHORN