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Imfinzi With Enfortumab Vedotin Improves Survival in Phase III Bladder Cancer Trial

The interim VOLGA readout points to a potential new option for patients who cannot receive cisplatin.

Overview

  • Perioperative Imfinzi paired with pre-surgery enfortumab vedotin, which AstraZeneca disclosed Thursday, improved event-free and overall survival versus surgery alone in muscle-invasive bladder cancer.
  • A second regimen that also included Imjudo raised event-free survival but did not reach statistical significance for overall survival at this interim check.
  • Safety matched the known profiles of the drugs with no new safety issues reported.
  • VOLGA is a global Phase III study of 695 people that tested therapy before and after surgery across three groups against standard radical cystectomy.
  • AstraZeneca plans to present full data and engage regulators next, a step that could change care for many patients who cannot take cisplatin due to kidney problems or other health issues.