AstraZeneca (AZ) has announced the voluntary withdrawal of its immunotherapy Imfinzi in its advanced bladder cancer indication in the US.

The US Food and Drug Administration (FDA) granted Imfinzi (durvalumab) an accelerated approval in May 2017 in advanced bladder cancer, after the Phase I/II Study 1108 of the immunotherapy demonstrated promising tumour response rates and duration of response data in advanced solid tumours – including previously-treated bladder cancer.

The continued approval of Imfinzi in this indication was dependent on positive results from AZ’s Phase III DANUBE trial in the first-line, metastatic bladder cancer. However, the immunotherapy did not meet the primary endpoints of this study in 2020.

Imfinzi monotherapy did not meet its primary endpoints of improving overall survival (OS) compared to standard of care, for patients whose tumour cells and/or tumour-infiltrating immune cells express high levels (≥25%) of PD-L1.

In addition, the company says Imfinzi in addition to tremelimumab missed its primary endpoint in patients regardless of their PD-L1 expression.

Following these disappointing results, AZ has decided to withdraw Imfinzi in this particular indication, a decision which was made in consultation with the FDA.

In a statement, AZ said that this withdrawal does not impact the indication outside the US, or the other approved indications for Imfinzi both within and outside the US.

“The science of immunotherapy has moved swiftly over the past few years, bringing new options to patients at an unprecedented pace,” said Dave Fredrickson, executive vice president, oncology business unit, at AZ.

“While the withdrawal in previously treated metastatic bladder cancer is disappointing, we respect the principles FDA set out when the accelerated approval pathway was founded and remain committed to bringing new and innovative options to patients,” he added.