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March 6, 2020updated 12 Jul 2022 11:57am

AstraZeneca’s DANUBE trial fails to meet primary endpoints

AstraZeneca has reported that the Phase III DANUBE trial for Imfinzi (durvalumab) and tremelimumab did not meet the primary endpoints of improving overall survival (OS) versus standard-of-care (SoC) chemotherapy for Imfinzi monotherapy in patients.

AstraZeneca has reported that the Phase III DANUBE trial for Imfinzi (durvalumab) and tremelimumab did not meet the primary endpoints of improving overall survival (OS) versus standard-of-care (SoC) chemotherapy for Imfinzi monotherapy in patients.

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
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The randomised, open-label, multi-centre, global trial compared Imfinzi and Imfinzi plus tremelimumab in unresectable, stage IV (metastatic) bladder cancer.

Imfinzi is a human monoclonal antibody that binds to PD-L1. It blocks the interaction of PD-L1 with PD-1 and CD80, opposing the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Tremelimumab is another human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4).

AstraZeneca Oncology R&D executive vice-president José Baselga 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.”

AstraZeneca conducted the trial at more than 220 centres across 24 countries.

The company noted that the safety and tolerability profiles for Imfinzi and the combination with tremelimumab remained consistent with previous trials.

The trial was conducted for patients with transitional cell carcinoma of the urothelium, including renal pelvis, ureters, urinary bladder, and urethra.

In January this year, AstraZeneca reported that the Phase III THALES clinical trial of Brilinta (ticagrelor) met its primary endpoint in patients who had a minor acute ischaemic stroke or high-risk transient ischaemic attack (TIA).

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

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