POTOMAC
Adding a year of durvalumab to standard BCG bladder instillations cut the risk of recurrence or progression by about a third, the first systemic immunotherapy approved in early bladder cancer.
DFS HR 0.68 (95% CI 0.50-0.93). FDA approval 28 May 2026. The first checkpoint inhibitor in BCG-naive NMIBC; raises questions of overtreatment given BCG's long-term success in many patients and adds systemic toxicity to a bladder-only disease.
- The treated group had about 32 percent lower chance of the event at any given time (hazard ratio 0.68).
- The absolute difference, how many more people out of 100 were helped, is not reported here.
- 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.
- These results apply to the people the trial enrolled: BCG-naive high-risk non-muscle-invasive bladder cancer: durvalumab + BCG (induction and maintenance) vs BCG. 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.
1,018 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Disease-free survivalprimary | Durvalumab + BCG (induction + maintenance) | — | — | 0.68 (0.5–0.93) | 0.0154 | link |
| BCG (induction + maintenance) | — | — |
Pages like this
not linked directly; found by shared links- TrialNIAGARA
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.
- TrialQUILT 3.032
- IdeaTrain the bone marrow to make better anti-tumour immune cells
- TechnologyIntravesical therapy (BCG, chemotherapy, devices, gene and viral therapy)
Shares Non-muscle-invasive vs muscle-invasive bladder cancer (NMIBC / MIBC), Intravesical BCG, Bladder & urothelial cancer.
- TermBCG-unresponsive
- Key paperNIAGARA: durvalumab before and after cystectomy for muscle-invasive bladder cancer
Shares Durvalumab, Bladder & urothelial cancer.