Durvalumab granted breakthrough therapy designation by US FDA for treatment of patients with PD-L1 positive urothelial bladder cancer

Wednesday, 17 February 2016

AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for durvalumab (MEDI4736), an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1), for the treatment of patients with PD-L1 positive inoperable or metastatic urothelial bladder cancer whose tumor has progressed during or after one standard platinum-based regimen.

Robert Iannone, Senior Vice President, Head of Immuno-Oncology, Global Medicines Development at AstraZeneca said: “Metastatic bladder cancer is an area of enormous unmet medical need. We are encouraged by this Breakthrough Therapy Designation. We look forward to working closely with the FDA to bring durvalumab to bladder cancer patients as soon as possible.”

The Breakthrough Therapy Designation is designed to expedite the development of new drugs that are intended to treat a serious condition and that have shown encouraging early clinical results, which demonstrate substantial improvement on a clinically significant endpoint over available therapies or when there is significant unmet medical need.

The Breakthrough Therapy Designation for durvalumab was granted by the FDA on the basis of early clinical data from a Phase I trial (Study 1108) in patients with advanced metastatic urothelial bladder cancer whose tumors had progressed during or after one standard platinum-based regimen. This represents the third Breakthrough Therapy Designation AstraZeneca has received from the FDA for medicines in oncology. This designation offers the opportunity for further collaboration with the FDA for the durvalumab development program. Data from study 1108 have been submitted for presentation at a future medical meeting.

Durvalumab is also being tested in first-line bladder cancer as a monotherapy, as well as in combination with tremelimumab as part of the DANUBE Phase III trial which enrolled its first patient during the final quarter of 2015.


About bladder cancer

Urothelial bladder cancers arise from the epithelium of the bladder and are the ninth most common form of cancer worldwide. Based on the Global Burden of Disease Cancer Collaboration, it is estimated that there were 400,000 incidents of bladder cancer and 173,000 deaths worldwide for the year 2013. Metastatic bladder cancer remains an area of great unmet medical need with five-year overall survival rates of less than 15 percent.

About durvalumab (MEDI4736)

Durvalumab is an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1). PD-L1 can be expressed by tumors to evade detection by the immune system through binding to PD-1 on cytotoxic T lymphocytes. Durvalumab blocks the PD-L1 interaction with PD-1, countering the tumor's immune-evading tactics. Durvalumab is being developed, alongside other immunotherapies, to empower the patient's immune system and attack the cancer. Durvalumab is being investigated in an extensive clinical trial program, as monotherapy or in combination with tremelimumab, in non-small cell lung cancer, head and neck, bladder, gastric, pancreatic, HCC and blood cancers.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least 6 new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advancing New Oncology as one of AstraZeneca’s six Growth Platforms, focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in hematology.

By harnessing the power of four scientific platforms -- immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates -- and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit www.astrazeneca-us.com.


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