AstraZeneca opens the door to Imfinzi expansion with trial win in high-risk bladder cancer patients

Title

AstraZeneca's Imfinzi Achieves Breakthrough in Treating High-Risk Bladder Cancer

Keywords

AstraZeneca, Imfinzi, Durvalumab, High-Risk Bladder Cancer, POTOMAC Trial

Key Facts

1. Clinical Trial Success:
The IMFINZI regimen demonstrated a statistically significant and clinically meaningful improvement in disease-free survival for high-risk non-muscle invasive bladder cancer (NMIBC) patients in the POTOMAC Phase III trial1.

2. Treatment Regimen:
The treatment included IMFINZI (durvalumab) combined with Bacillus Calmette-Guérin (BCG) therapy, ensuring that patients' ability to complete BCG induction and maintenance was not compromised3.

3. FDA Approvals:
Recently, Imfinzi received FDA approval for use in perioperative settings for muscle-invasive bladder cancer (MIBC), marking it as the first immunotherapy cleared for this purpose. It is used alongside chemotherapies before surgery and alone afterward45.

4. Expansion Opportunities:
This success opens doors for further expansion of Imfinzi's use across various bladder cancer types, offering new treatment options and enhancing patient outcomes25.

Sources:

1. http://www.astrazeneca-us.com/media/press-releases/2025/IMFINZI-durvalumab-regimen-demonstrated-statistically-significant-and-clinically-meaningful-improvement-in-disease-free-survival-for-high-risk-non-muscle-invasive-bladder-cancer-in-POTOMAC-Phase-III-trial.html

2. https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-approved-in-the-us-for-bladder-cancer.html

3. https://firstwordpharma.com/story/5959147

4. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer

5. https://www.fiercepharma.com/pharma/astrazeneca-bulks-imfinzis-perioperative-prowess-fda-win-bladder-cancer