9th May 2025 09:29
(Alliance News) - AstraZeneca PLC on Friday said it has received positive data from a trial evaluating Imfinzi as a treatment for patients with high-risk non-muscle-invasive bladder cancer.
The Cambridge-based pharmaceuticals company said Imfinzi, or durvalumab, demonstrated a significant and clinically meaningful improvement in disease-free survival in the Potomac phase 3 trial compared to the current standard of care alone.
The Potomac trial looked at one year of treatment in patients using Imfinzi plus standard-of-care BCG induction and maintenance therapy. The trial was not statistically powered to formally test overall survival rate, AstraZeneca noted, but a descriptive analysis showed no detriment.
More than 70% of bladder cancer patients are diagnosed with non-muscle-invasive bladder cancer, an early-stage cancer where the tumour is in the tissue lining the inner surface of the bladder but has not yet invaded the muscle wall.
Around half of patients with non-muscle-invasive bladder cancer are considered at high risk of disease progression or recurrence.
"The positive results for Imfinzi in the Potomac trial represent a significant advance that will potentially allow more patients with early-stage bladder cancer to benefit from this important immunotherapy," said Cristian Massacesi, chief medical officer and Oncology chief development officer at AstraZeneca.
"Building on the Niagara data, this outcome demonstrates our strategy of bringing novel therapies to patients with early-stage disease where there is the greatest potential for long-term benefit."
Imfinzi is currently approved for use in the US and other countries for patients with muscle-invasive bladder cancer, based on results from the Niagara phase 3 trial.
The treatment continues to be investigated across early and late-stage bladder cancer in various treatment combinations, including in patients with MIBC who are ineligible or refuse to take cisplatin, and in locally advanced or metastatic disease.
Shares in AstraZeneca were up 0.5% at 10,180.00 in London on Friday morning.
By Emily Parsons, Alliance News reporter
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