Company: AZN
Filing Date: 2025-05-09
Form Type: 6-K
Source: 0001654954-25-005331
Chunk: 2

Company: ASTRAZENECA PLC
Filing Date: 2025-05-09
Form: 6-K
Chunk 2
---
platin (VOLGA) and in locally advanced or metastatic disease (NILE).

#### Notes

#### Bladder cancer
Bladder cancer is the 9th most common cancer in the world, with more than 614,000 cases diagnosed each year. 4 The most common type is urothelial carcinoma, which begins in the urothelial cells of the urinary tract. 2

In 2024, an estimated 125,000 patients were treated for high-risk NMIBC, for which the current standard of care is transurethral resection of bladder tumour (TURBT) followed by administration of BCG directly into the bladder. 5-6 Up to 80% of patients experience disease recurrence within five years, and rates of progression in high-risk patients can be as high as 45%. 2 There is a critical need for treatment options in this curative-intent setting.

#### POTOMAC
POTOMAC is a randomised, open-label, multi-centre, global Phase III trial evaluating Imfinzi in combination with BCG therapy as a treatment for 1,018 patients with high-risk, BCG-naïve NMIBC who have undergone TURBT prior to randomisation. Patients were randomised 1:1:1 to receive Imfinzi plus BCG induction and maintenance therapy, or Imfinzi plus BCG induction-only therapy, versus standard-of-care BCG induction and maintenance therapy.

The trial was conducted in more than 120 centres across 12 countries including Canada and others across Europe and Asia. The primary endpoint was DFS, defined as time from randomisation to date of first recurrence of high-risk disease or death from any cause, for Imfinzi plus BCG induction and maintenance therapy compared to BCG induction and maintenance therapy alone. Secondary endpoints included DFS for Imfinzi plus BCG induction only therapy versus the comparator arm, as well as OS at five years and safety across both experimental arms of the trial.

#### Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses.

In addition to its indication in MIBC, Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III non-small cell lung