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Update on Phase III DANUBE trial in bladder cancer
Update on Phase III DANUBE trial in bladder cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n RNS Number : 2577F\n AstraZeneca PLC\n 06 March 2020\n \n \n \n 6 March 2020 07:00 GMT\n \n \n Update on Phase III DANUBE trial for Imfinzi and\ntremelimumab in unresectable, Stage IV bladder cancer\n \n \n \n \n The Phase III DANUBE trial for Imfinzi (durvalumab) and Imfinzi plus tremelimumab in unresectable, Stage IV (metastatic) bladder cancer did not meet the primary endpoints of improving overall survival (OS) versus standard-of-care (SoC) chemotherapy for Imfinzi monotherapy in patients whose tumour cells and/or tumour-infiltrating immune cells express high levels (≥25%) of PD-L1, or for Imfinzi plus tremelimumab in patients regardless of their PD-L1 expression.\n \n \n \n \n José Baselga, Executive Vice President, Oncology R&D, said: \"AstraZeneca remains 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.\"\n \n \n \n \n The safety and tolerability profiles for Imfinzi and the combination with tremelimumab were consistent with previous trials. The data will be presented at a forthcoming medical meeting.\n \n \n \n \n \n Imfinzi\n \n is being \n 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. 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.\n \n \n \n \n \n \n Imfinzi\n \n is approved for patients with locally advanced or metastatic bladder cancer previously treated with platinum-containing chemotherapy in 15 countries, including the US.\n \n \n \n Bladder cancer\n \n \n In 2018, approximately 550,000 people were diagnosed with bladder cancer around the world and 200,000 died from the disease.1 Locally advanced and metastatic bladder cancer r...