Imfinzi (durvalumab) and Imfinzi plus tremelimumab failed to meet its primary endpoint in a Phase III trial, AstraZeneca has reported.
The Phase III DANUBE trial intended to demonstrate improved overall survival (OS) verses standard-of-care (SoC) chemotherapy for Imfinzi monotherapy and Imfinzi plus tremelimumab in unresectable, stage IV bladder cancer.
Despite failing to meet its primary endpoints, the safety and tolerability profiles for Imfinzi and the combination with tremelimumab were consistent with previous trials.
“The results from this trial will inform our comprehensive Phase III development programme in bladder cancer,” said José Baselga, AstraZeneca’s Executive Vice President of Oncology R&D.
“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.”
Imfinzi is being developed 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.
It 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.
The treatment is currently approved for patients with locally advanced or metastatic bladder cancer previously treated with platinum-containing chemotherapy in 15 countries, including the US.