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Perioperative IMFINZI® (durvalumab) approved in the US in novel regimen with neoadjuvant enfortumab vedotin-ejfv for patients with muscle-invasive bladder cancer

AZN
  • The US FDA has approved AstraZeneca's IMFINZI (durvalumab) combined with enfortumab vedotin-ejfv (EV) as neoadjuvant treatment, followed by IMFINZI monotherapy as adjuvant therapy, for adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or have refused cisplatin-based chemotherapy.
  • Approval was granted following a Priority Review based on results from the VOLGA Phase III trial, with data presented at the 2026 ESMO Congress and published in The New England Journal of Medicine.
  • Clinical trial results demonstrated a 49% reduction in the risk of disease progression, recurrence, failure to undergo surgery, or death (event-free survival hazard ratio of 0.51) and a 42% reduction in the risk of death (overall survival hazard ratio of 0.58) compared to the standard of care.
  • The treatment regimen consists of three cycles of IMFINZI plus EV prior to radical cystectomy, followed by nine cycles of IMFINZI monotherapy after surgery.
  • Approximately 50% of MIBC patients are ineligible for cisplatin due to impaired renal function or comorbidities, and historical outcomes with radical cystectomy alone involve high recurrence rates.
  • The safety profile of the combination was manageable, with Grade 3 or 4 adverse events occurring in 64% of patients in the treatment arm versus 44% in the comparator arm, and no new safety signals identified.
  • Estimated median event-free survival was not reached for the IMFINZI combination arm, compared to 12.1 months for the comparator arm, with 64% of patients remaining alive and event-free at two years versus 45% in the comparator arm.
  • Estimated median overall survival was not reached for either arm, with 78% of patients treated with the IMFINZI combination alive at two years compared to 69% in the comparator arm.
  • Regulatory applications for the IMFINZI and EV regimen are currently under review in the European Union, Japan, and other countries.
  • The approval reinforces IMFINZI as an immunotherapy backbone across both muscle-invasive and non-muscle-invasive bladder cancer indications.
  • Important safety information includes warnings for severe and fatal immune-mediated adverse reactions affecting various organ systems, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and dermatology reactions.
  • IMFINZI is currently approved in over 50 countries for various solid tumors, including non-small cell lung cancer, small cell lung cancer, biliary tract cancer, hepatocellular carcinoma, endometrial cancer, and gastric cancer.