Global pharma powerhouse AstraZeneca has reported major clinical advances from its Phase III VOLGA trial in muscle-invasive bladder cancer.

 

The study has shown that perioperative treatment with Imfinzi (durvalumab), alone or in combination with other immunotherapy agents, significantly improves key survival outcomes in patients who cannot receive standard cisplatin chemotherapy.

 

The planned interim analysis found that perioperative Imfinzi plus neoadjuvant enfortumab vedotin (EV) delivered “statistically significant and clinically meaningful improvements in event-free survival and overall survival” compared with surgery-based standard care in patients.

 

These patients were either ineligible for or had declined cisplatin-based chemotherapy.

 

A second experimental regimen—Imfinzi combined with Imjudo (tremelimumab) and neoadjuvant EV—also showed “a statistically significant and clinically meaningful improvement in event-free survival and a favourable trend for overall survival,” though the overall survival results were not yet statistically significant at this interim stage and will be reassessed in a later analysis.

 

The VOLGA trial enrolled patients with muscle-invasive bladder cancer, a condition affecting roughly one in four bladder cancer cases. Up to 50% of patients are unable to receive cisplatin due to kidney impairment or other comorbidities, leaving surgery alone as the historical standard of care—despite high recurrence rates and poor long-term outcomes.

 

Professor Thomas Powles, International Coordinating Investigator for the study, said: “Up to half of patients with muscle-invasive bladder cancer are not eligible for cisplatin and face high rates of disease recurrence, even after having their bladder removed, leaving a significant need for new effective and well-tolerated treatments. 

 

"The VOLGA results show that perioperative durvalumab significantly extends event-free survival and overall survival when combined with neoadjuvant enfortumab vedotin, with a manageable safety profile, compared with surgery for patients in this curative-intent setting.”

 

AstraZeneca’s Oncology R&D head Susan Galbraith said: “This interim analysis from the VOLGA trial highlights the benefit of perioperative Imfinzi with neoadjuvant enfortumab vedotin compared to surgery, a novel regimen that optimises treatment options for patients. 

 

"Together with NIAGARA and POTOMAC, VOLGA is our third positive readout in bladder cancer, setting a strong foundation for Imfinzi as the immunotherapy backbone in this early-stage, curative-intent setting.”

 

Safety data from the trial showed no new safety signals, with tolerability consistent with the known profiles of the individual therapies.

 

The company said the results will be presented at an upcoming medical meeting and submitted to global regulators, as it expands its push to establish Imfinzi as a backbone immunotherapy across earlier-stage bladder cancer treatment.

 

Bladder cancer remains a major global health burden, with more than 614,000 cases diagnosed annually worldwide. Around 117,500 patients are treated each year for muscle-invasive disease, yet approximately half are ineligible for cisplatin-based chemotherapy and many still experience recurrence after surgery alone.

 

The VOLGA study is part of AstraZeneca’s broader oncology strategy to move immunotherapy into earlier, potentially curative treatment settings. Imfinzi is already approved in several countries for bladder and multiple other cancers, and is being evaluated across a wide pipeline of tumour types.