AstraZeneca’s Imfinzi (durvalumab), combined with neoadjuvant enfortumab vedotin (EV), significantly improved survival outcomes in patients with muscle-invasive bladder cancer (MIBC).

 

This, cutting the risk of death by 42% and the risk of disease progression, recurrence, failure to undergo surgery or death by 49%, according to results from the Phase III VOLGA trial.

 

The findings, which demonstrated statistically significant and clinically meaningful improvements in both event-free survival (EFS) and overall survival (OS), could pave the way for a new treatment approach for patients who are ineligible for or have refused cisplatin-based chemotherapy.

 

In a planned interim analysis, patients receiving perioperative Imfinzi alongside neoadjuvant EV had a 49% lower risk of disease progression, recurrence, not undergoing surgery or death than those in the comparator arm, which received radical cystectomy, or bladder-removal surgery, with or without approved adjuvant treatment.

 

The event-free survival hazard ratio was 0.51. Median EFS had not yet been reached in the Imfinzi combination arm, compared with 12.1 months in the comparator arm.

 

At two years, an estimated 64% of patients receiving the Imfinzi combination remained alive and event-free, compared with 45% of those in the comparator arm.

 

The overall survival results were similarly encouraging. The Imfinzi combination reduced the risk of death by 42% compared with the comparator arm, with an OS hazard ratio of 0.58.

 

Median overall survival had not yet been reached in either arm. However, an estimated 78% of patients treated with the Imfinzi combination were alive at two years, compared with 69% in the comparator arm.

 

Thomas Powles, Professor and Chair of Barts Cancer Centre at Barts Health NHS Trust, London, UK, and international coordinating investigator for the VOLGA trial, said: “Patients with muscle-invasive bladder cancer require life-changing bladder removal surgery. Despite this, the cancer returns in about half of patients. A new regimen of perioperative durvalumab combined with enfortumab vedotin before surgery reduced the risk of death by 42%, with a manageable safety profile. These practice-changing results support this approach as a patient centric, potential new standard of care in this setting.”

 

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “The VOLGA data show that more than three quarters of patients were still alive two years after treatment with the novel regimen of perioperative Imfinzi and neoadjuvant enfortumab vedotin, with quality of life maintained, allowing physicians to optimise treatment for patients in this curative-intent setting. These compelling results reinforce the potential for Imfinzi to become the immunotherapy backbone treatment across muscle-invasive and non-muscle-invasive bladder cancer.”