AstraZeneca announces results from interim analysis of VOLGA Phase III trial

High-level results from a planned interim analysis of the VOLGA Phase III trial showed perioperative treatment with IMFINZI in combination with neoadjuvant enfortumab vedotin demonstrated statistically significant and clinically meaningful improvements in event-free survival and overall survival in patients with muscle-invasive bladder cancer versus standard of care. Patients were ineligible for or had declined cisplatin-based chemotherapy. Patients in the comparator arm had a radical cystectomy with or without approved adjuvant treatment. Perioperative IMFINZI plus IMJUDO in combination with neoadjuvant EV demonstrated a statistically significant and clinically meaningful improvement in EFS and a favorable trend for OS; however, the OS data were not statistically significant at this planned interim analysis and will be formally reassessed at a subsequent analysis. Approximately one in four patients with bladder cancer has muscle-invasive disease, where the tumor invades the muscle wall of the bladder, without distant metastases. As many as 50% of patients are ineligible for cisplatin-based chemotherapy due to impaired renal function or comorbidities. The standard treatment for these patients has historically been radical cystectomy alone but, despite undergoing this major surgery, patients experience high rates of recurrence and have a poor prognosis. The safety and tolerability of IMFINZI with or without IMJUDO plus EV was consistent with the known safety profiles of the individual medicines, with no new safety signals identified. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities. IMFINZI is approved in over 40 countries for patients with cisplatin-eligible MIBC, based on the NIAGARA Phase III trial. Additionally, IMFINZI added to Bacillus Calmette-Guerin therapy met the primary endpoint of disease-free survival for patients with high-risk non-muscle-invasive bladder cancer in the POTOMAC Phase III trial and is currently under review in the US, European Union, Japan and several other countries. IMFINZI is also being investigated in locally advanced or metastatic disease in the NILE Phase III trial.