FDA grants priority review to perioperative durvalumab plus enfortumab vedotin in MIBC

The FDA has granted priority review to a supplemental biologics license application for perioperative durvalumab (Imfinzi) in combination with neoadjuvant enfortumab vedotin-ejfv (Padcev; EV) for patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or have declined cisplatin-based chemotherapy.¹

The agency issued a PDUFA target action date in the fourth quarter of 2026.

The application is supported by data from the phase 3 VOLGA trial, which demonstrated at an interim analysis that perioperative durvalumab plus neoadjuvant EV significantly improved event-free survival (EFS) and overall survival (OS) vs standard-of-care with radical cystectomy with or without approved adjuvant treatment. According to AstraZeneca, the safety profile for the combination was consistent with the known safety profile of the individual agents. No new safety signals were observed in the trial.

The company noted that full results from the trial will be presented at an upcoming medical meeting.

About the VOLGA trial

VOLGA (NCT04960709) is an open-label, global phase 3 trial evaluating perioperative durvalumab with or without tremelimumab in combination with enfortumab vedotin in patients with MIBC who were either ineligible for or declined cisplatin-based chemotherapy.²

The study enrolled patients with stage T2-T4aN0/1M0 MIBC or stage T1N1M0 urothelial carcinoma who were candidates for radical cystectomy. Participants also needed to have an ECOG performance status of 0 to 2 at the time of enrollment and no prior receipt of systemic chemotherapy or immunotherapy for MIBC.

Patients were randomly assigned to receive durvalumab plus enfortumab vedotin, durvalumab with tremelimumab-actl (Imjudo) plus enfortumab vedotin, or standard-of-care surgery with or without approved adjuvant therapy. The primary end points include EFS and safety. Secondary end points include pathologic complete response rate, OS, disease-free survival, and quality-of-life measures.

In addition to the durvalumab + EV arm, a separate treatment arm evaluating perioperative durvalumab plus tremelimumab in combination with neoadjuvant enfortumab vedotin also met the EFS end point and demonstrated a favorable OS trend. However, the OS findings for the triplet regimen did not meet statistical significance at the interim analysis and will be re-evaluated in a future assessment.³

The combination of perioperative durvalumab plus neoadjuvant EV is also under review in the EU, Japan, and several other countries based on the results from the VOLGA trial.

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REFERENCES

1. Perioperative IMFINZI® (durvalumab) plus neoadjuvant enfortumab vedotin granted Priority Review in the US for patients with muscle-invasive bladder cancer. News release. AstraZeneca. September 25, 2026. Accessed September 25, 2026. https://www.astrazeneca-us.com/content/az-us/media/press-releases/2026/Perioperative-IMFINZI-durvalumab-plus-neoadjuvant-enfortumab-vedotin-granted-Priority-Review-in-the-US-for-patients-with-muscle-invasive-bladder-cancer.html

2. Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin (VOLGA). ClinicalTrials.gov. June 4, 2026. Accessed September 25, 2026. https://clinicaltrials.gov/study/NCT04960709

3. Perioperative IMFINZI® (durvalumab) plus neoadjuvant EV showed statistically significant and clinically meaningful improvements in event-free survival and overall survival in muscle-invasive bladder cancer in the phase III VOLGA trial. News release. AstraZeneca. May 14, 2026. Accessed September 25, 2026. https://www.astrazeneca-us.com/content/az-us/media/press-releases/2026/Perioperative-IMFINZI-durvalumab-plus-neoadjuvant-EV-showed-statistically-significant-and-clinically-meaningful-improvements-in-event-free-survival-and-overall-survival-in-muscle-invasive-bladder-cancer-in-the-Phase-III-VOLGA-trial.html