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AstraZeneca's Phase III Danube Trial Fails To Meet Primary Endpoint

6th Mar 2020 08:07

(Alliance News) - AstraZeneca PLC on Friday said its phase III Danube trial for bladder cancer treatments, Imfinzi and Imfinzi plus tremelimumab, did not meet the primary endpoints.

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

The trial was conducted in more than 220 centres across 24 countries, Astra said, including the US, Europe, South America, Asia, Australia and the Middle East.

The blue-chip drugmaker said the treatments did not improve overall survival in patients whose tumour cells have a high level of protein PD-L1, when compared with standard chemotherapy.

"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 first-line metastatic setting, and we continue to advance clinical trials for patients at earlier stages of the disease," said Jose Baselga, executive vice president Oncology R&D.

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.

The stock was 0.9% lower at 7,435.00 pence a share on Friday morning in London.

By Ife Taiwo; [email protected]

Copyright 2020 Alliance News Limited. All Rights Reserved.


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