AstraZeneca’s Imfinzi (durvalumab) in combination with enfortumab vedotin (EV) has been accepted for Priority Review by the US FDA, for patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or have declined cisplatin-based chemotherapy.

 

The filing is based on results from the Phase III VOLGA trial, in which perioperative treatment with Imfinzi plus neoadjuvant EV delivered statistically significant and clinically meaningful improvements in event-free survival (EFS) and overall survival (OS) compared with radical cystectomy, with or without approved adjuvant treatment.

 

“This Priority Review reinforces the potential of Imfinzi to become the immunotherapy backbone treatment for muscle-invasive bladder cancer, where patients face high rates of recurrence despite bladder removal surgery. If approved, this would be the first perioperative regimen with enfortumab vedotin given only before surgery; a potentially new standard of care offering practice-changing efficacy and tolerability in this curative-intent setting," Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said.

 

MIBC accounts for roughly one in four bladder cancer cases and occurs when a tumour has invaded the muscle wall of the bladder without spreading to distant sites. Up to half of patients may be ineligible for cisplatin-based chemotherapy because of impaired kidney function or other comorbidities.

 

For these patients, radical cystectomy has historically been the standard approach. However, recurrence rates remain high even after bladder removal, leaving patients with a poor prognosis.

 

In the VOLGA trial, the safety and tolerability profile of Imfinzi plus EV was consistent with the known safety profiles of the individual medicines, with no new safety signals identified.

 

The regulatory submission is also under review in the European Union, Japan and several other countries.

 

Imfinzi is already approved in more than 50 countries for patients with cisplatin-eligible MIBC, based on results from the Phase III NIAGARA trial. In the US, Japan and other countries, Imfinzi combined with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy is approved for patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer, based on the Phase III POTOMAC trial.