After consulting with the U.S. Food and Drug Administration (FDA), AstraZeneca has announced that Imfinzi (durvalumab) — which last year failed a confirmatory Phase 3 trial — will no longer be available in the U.S. for people with locally advanced or metastatic bladder cancer.
AstraZeneca has opted to voluntarily withdraw Imfinzi after the therapy’s failure, in 2020, to meet the goals of the Phase 3 DANUBE trial. Data showed that Imfinzi did not work better than chemotherapy in extending the lives of bladder cancer patients who had previously received other therapies.
According to an AstraZeneca press release, healthcare professionals are being informed of the company’s decision. Patients with advanced bladder cancer who are currently being treated with Imfinzi in the U.S. should visit their healthcare providers to discuss their options and to select the best course of treatment after discontinuing Imfinzi.
Importantly, this market withdrawal does not have any impact on other indications for which Imfinzi is currently approved, both within and outside the U.S. The FDA has approved the therapy for certain forms of advanced lung cancers.
Imfinzi belongs to a class of medications known as immune checkpoint inhibitors, which block the activity of proteins often exploited by cancer cells as part of a survival mechanism, due to their ability to shut down immune system responses. By inhibiting these proteins, medications like Imfinzi are expected to boost immune cells’ effectiveness at recognizing and eliminating malignant cancer cells.
The FDA granted conditional approval to Imfinzi in 2017 for the treatment of patients with advanced bladder cancer whose disease had progressed despite having been previously treated with platinum-containing chemotherapy, with or without surgery. This approval was based on the promising response rates and response duration seen in the Phase 1/2 Study 1108 (NCT01693562), which enrolled patients with different types of advanced solid tumors.
In line with criteria established by the FDA, Imfinzi’s continued approval for advanced bladder cancer was dependent on confirmation of its positive effects in a larger clinical trial.
However, data from DANUBE (NCT02516241), a Phase 3 trial designed to confirm Imfinzi’s benefits in these patients, showed that the treatment was not superior to standard chemotherapy at extending survival.
Based on these findings and after consulting with the FDA, AstraZeneca decided to voluntarily withdraw Imfinzi’s approval for this indication.
“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,” said Dave Fredrickson, executive vice president of the oncology business unit at AstraZeneca.
Of note, Imfinzi is being investigated, both alone and in combination with other agents, as a possible treatment for liver, gastric, cervical, ovarian, and endometrial cancers.
