LONDON (dpa-AFX) - AstraZeneca Plc. (AZN, AZN.L) announced that results from the POTOMAC Phase III trial showed that one year of treatment with its Imfinzi (durvalumab), combined with standard Bacillus Calmette-Guérin (BCG) induction and maintenance therapy, significantly improved disease-free survival in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) compared to BCG induction and maintenance therapy alone.
The trial was not statistically powered to formally test overall survival (OS) however a descriptive analysis demonstrated no detriment.
The company noted that the safety and tolerability of Imfinzi plus BCG induction and maintenance therapy was consistent with the known safety profiles of the individual medicines, with no new safety concerns identified. The addition of?Imfinzi?did not compromise patients' ability to complete BCG induction and maintenance therapy.
The second experimental arm evaluating Imfinzi plus BCG induction-only therapy compared to BCG induction and maintenance therapy alone did not meet the endpoint of disease-free survival.
Imfinzi is approved in the US and other countries for patients with muscle-invasive bladder cancer (MIBC) based on results from the NIAGARA Phase III trial and 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 (VOLGA) and in locally advanced or metastatic disease (NILE).
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