AstraZeneca announced the Phase III DANUBE trial evaluating Imfinzi (durvalumab) alone and in combination with tremelimumab for patients with unresectable, Stage IV (metastatic) bladder cancer did not meet the primary endpoints of improving overall survival (OS) versus standard-of-care (SoC) chemotherapy. Full data will be presented at a forthcoming medical meeting.
DANUBE was a randomized, open-label, multi-center, global trial in the 1st-line treatment of both cisplatin eligible and ineligible patients with unresectable, Stage IV (metastatic) UC. The trial compared Imfinzi monotherapy or Imfinzi plus tremelimumab versus cisplatin and gemcitabine or carboplatin and gemcitabine chemotherapy. The trial was conducted in more than 220 centers across 24 countries, including centers in the US, Canada, Europe, South America, Asia, Australia and the Middle East.
The primary endpoints of the trial were OS in high PD-L1 patients treated with Imfinzi monotherapy, and OS in patients treated with Imfinzi plus tremelimumab regardless of their PD-L1 status. OS was not reached in either patient treatment group.
The DANUBE trial was part of a post-approval commitment in agreement with the US Food and Drug Administration from the May 2017 accelerated US approval of Imfinzi in previously treated patients with advanced bladder cancer.
Imfinzi is being evaluated in patients with unresectable, locally advanced or metastatic bladder cancer in the Phase III NILE trial either in combination with chemotherapy or with chemotherapy and tremelimumab. Imfinzi is also being tested in earlier stages of bladder cancer in the Phase III NIAGARA trial in combination with chemotherapy, and in the Phase III POTOMAC trial in combination with SoC Bacillus Calmette-Guerin immunotherapy.
Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses.
About Bladder cancer
In 2018, approximately 550,000 people were diagnosed with bladder cancer around the world and 200,000 died from the disease. Only one in seven patients are typically alive five years after diagnosis. Urothelial cancer (UC) is the most common form of bladder cancer. UC is the 10th most common cancer worldwide and the 13th most common cause of cancer death. PD-L1 is widely expressed in tumor and immune cells in patients with bladder cancer and helps tumors evade detection from the immune system.