Withdrawal of Durvalumab for Advanced Bladder Cancer “a Disappointing Loss”

The drug failed to meet its primary endpoints in study

• In February 2021, AstraZeneca voluntarily withdrew the durvalumab (brand name: Imfinzi) indication for previously treated advanced bladder cancer
• The FDA had granted accelerated approval to the checkpoint inhibitor in 2017 based on promising preliminary study results
• In the follow-up DANUBE trial, durvalumab did not provide a survival benefit

On February 22, 2021, AstraZeneca announced that it was voluntarily withdrawing the checkpoint inhibitor durvalumab (brand name: Imfinzi) indication for previously treated patients with locally advanced or metastatic bladder cancer.

The FDA had granted durvalumab accelerated approval in 2017, based on promising responses from a phase I/II trial in advanced solid tumors. However, in the follow-up DANUBE phase II/III trial, the drug failed to meet its primary endpoints.

“Initially it was thought that immune checkpoint blockade has an ongoing, prolonged effect due to the fact that it stimulates the immune system,” Dr. Roger Li, urologic oncologist at the Moffitt Cancer Center in Tampa, FL, tells SurvivorNet Connect. “But based on the emerging data that came out…Imfinzi actually did not provide a survival benefit for metastatic bladder cancer in general, hence the removal.”

In a group of patients that often experience recurrence after chemotherapy, the withdrawal of durvalumab was “truly a disappointing loss,” Dr. Li says. However, he adds that in many clinical practices, most patients with chemorefractory tumors are put on pembrolizumab (Keytruda). “I don’t think that Imfinzi has a huge role in that setting anyway.”