Loading
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.
POTOMAC, trial NCT03528694 sponsored by AstraZeneca and reported in 2025, showed that adding a year of durvalumab to standard BCG bladder instillations in BCG-naive high-risk non-muscle-invasive bladder cancer cut the risk of recurrence or progression by about a third, making it the first systemic immunotherapy approved in early bladder cancer. It randomised 1,018 patients to durvalumab plus BCG induction and maintenance or BCG alone, met its primary disease-free survival endpoint and led to FDA approval on 28 May 2026. OnCo links it to bladder cancer, durvalumab, intravesical BCG, the NMIBC term and the pairing of durvalumab with BCG. The result raises questions of overtreatment, since BCG alone succeeds long term in many patients, and adds systemic toxicity to a bladder-only disease, which 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.
1,018 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Disease-free survivalprimary | Durvalumab + BCG (induction + maintenance) | - | - | 0.68 (0.5 to 0.93) | 0.0154 | link |
| BCG (induction + maintenance) | - | - |
Shares Non-muscle-invasive vs muscle-invasive bladder cancer (NMIBC / MIBC), Durvalumab, AstraZeneca, Bladder & urothelial cancer.
Shares Durvalumab, AstraZeneca, Bladder & urothelial cancer, Immune checkpoint inhibitors.
Shares Durvalumab, AstraZeneca, Bladder & urothelial cancer, Immune checkpoint inhibitors.
Shares Durvalumab, AstraZeneca, Bladder & urothelial cancer, Immune checkpoint inhibitors.
Shares Durvalumab, AstraZeneca, Bladder & urothelial cancer, Immune checkpoint inhibitors.
Shares Durvalumab, AstraZeneca, Bladder & urothelial cancer, Immune checkpoint inhibitors.
Shares Durvalumab, AstraZeneca, Immune checkpoint inhibitors.
Shares Durvalumab, AstraZeneca, Immune checkpoint inhibitors.