AstraZeneca has released an update from its Phase III DANUBE trial, assessing Imfinzi (durvalumab) and Imfinzi plus tremelimumab in unresectable, Stage IV (metastatic) bladder cancer.
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.
Despite the setback, AstraZeneca says that it “remains committed to addressing unmet needs in bladder cancer and the potential for immunotherapy to improve outcomes for these patients.”
José Baselga, executive vice president, oncology R&D went on to say: “The results from this trial will inform our comprehensive Phase III development programme in bladder cancer. We look forward to the results of the Phase III NILE trial also in the 1st-line metastatic setting, and we continue to advance clinical trials for patients at earlier stages of the disease.”
The AZ human monoclonal antibody is also being tested as a monotherapy and in combinations including with tremelimumab, as a treatment for other forms of cancer, including head and neck, liver and cervical.
In 2018, approximately 550,000 people were diagnosed with bladder cancer around the world and 200,000 died from the disease.
