# POTOMAC

Source: https://onco.cc/trials/potomac/  
OnCo record `potomac` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT03528694
- Phase: 3
- Setting: BCG-naive high-risk non-muscle-invasive bladder cancer: durvalumab + BCG (induction and maintenance) vs BCG
- Sponsor: AstraZeneca
- Enrolled: 1018
- Result: DFS HR 0.68.
- Outcomes: Disease-free survival: Durvalumab + BCG (induction + maintenance) vs BCG (induction + maintenance), HR 0.68
- Replication: KEYNOTE-676 (pembrolizumab + BCG) and CREST (sasanlimab + BCG, positive 2025) test the same concept; ALBAN (atezolizumab + BCG) was negative.

## Sources

- ClinicalTrials.gov NCT03528694: https://clinicaltrials.gov/study/NCT03528694

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Durvalumab](https://onco.cc/drugs/durvalumab/), [Intravesical BCG](https://onco.cc/drugs/bcg-intravesical/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/)
- terms: [Non-muscle-invasive vs muscle-invasive bladder cancer (NMIBC / MIBC)](https://onco.cc/terms/nmibc-vs-mibc/)
- pairings: [Durvalumab + BCG in BCG-naive high-risk NMIBC](https://onco.cc/pairings/durvalumab-plus-bcg/)

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JSON: https://onco.cc/api/v1/entities/potomac.json