AstraZeneca bladder treatment fails to met trial endpoint

AstraZeneca said its Imfinzi bladder cancer treatment did not meet primary endpoints in the phase three DANUBE trial against standard-of-care (SoC) chemotherapy for patients with an advanced stage 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, Astra said.

The drug 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.

Astra's executive vice-president for oncology José Baselga said the company remained committed to “addressing unmet needs in bladder cancer and the potential for immunotherapy to improve outcomes for these patients”.

“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," Baselga said.

In 2018, about 550,000 people were diagnosed with bladder cancer around the world and 200,000 died from the disease, Astra said.

Imfinzi is approved for patients with locally advanced or metastatic bladder cancer previously treated with platinum-containing chemotherapy in 15 countries, including the US.

It is also being tested as a monotherapy and in combinations including with tremelimumab, an anti-CTLA4 monoclonal antibody and potential new medicine, as a treatment for patients with bladder cancer, head and neck cancer, liver cancer, biliary tract cancer, cervical cancer and other solid tumours.