AstraZeneca’s Phase III VOLGA trial in 695 cisplatin-ineligible or cisplatin-declining patients with muscle-invasive bladder cancer found that perioperative Imfinzi plus Padcev significantly improved both event-free survival and overall survival versus standard care. The study adds a third late-stage bladder cancer win for durvalumab, while the Imfinzi/Imjudo/Padcev arm improved event-free survival but has not yet shown a statistically significant overall survival benefit.

Why It Matters To Oncology

• VOLGA targets a high-need muscle-invasive bladder cancer population: patients undergoing radical cystectomy who cannot receive or have declined cisplatin.

• AstraZeneca says up to 50% of patients with MIBC are ineligible for cisplatin-based chemotherapy, often because of renal impairment or comorbidities.

• If confirmed in full data, the regimen could help refine perioperative treatment decisions in Bladder Cancer beyond cisplatin-eligible patients.

• Safety was consistent with known profiles for Imfinzi, Imjudo and Padcev, with no new signals identified.

The Financials

• VOLGA is AstraZeneca’s third positive pivotal readout in bladder cancer, alongside NIAGARA and POTOMAC, strengthening Imfinzi’s franchise in early-stage, curative-intent disease.

• Imfinzi is already approved in more than 40 countries for cisplatin-eligible MIBC based on NIAGARA, and is under review in several markets for high-risk non-MIBC after POTOMAC.

• Positive survival data in a cisplatin-ineligible setting could expand the addressable perioperative market for durvalumab and support additional regulatory filings.

What They're Saying

• VOLGA coordinating investigator Thomas Powles said these patients face high recurrence rates even after bladder removal, underscoring the need for effective, well-tolerated options.

• AstraZeneca oncology R&D chief Susan Galbraith called VOLGA the company’s third positive bladder cancer readout and said it helps position Imfinzi as an immunotherapy backbone in early-stage disease.

• The company said data will be presented at a future medical meeting and shared with global regulators.

What's Next

• A later analysis will reassess overall survival in the Imfinzi plus Imjudo plus Padcev arm, where only a favorable trend has been seen so far.

• Clinicians will be watching for full hazard ratios, subgroup analyses and perioperative treatment details when VOLGA is presented.

• Regulatory submissions could follow if the detailed data support a favorable benefit-risk profile in cisplatin-ineligible MIBC.